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Latest Press Releases


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October 10, 2013
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FDA approves new pediatric use for Liposorber Apheresis System


October 08, 2013
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FDA approves Adempas to treat pulmonary hypertension


October 04, 2013
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FDA approves Clinolipid for intravenous nutrition


September 30, 2013
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FDA approves new drug to treat major depressive disorder

FDA approves Perjeta for neoadjuvant breast cancer treatment


September 25, 2013
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FDA awards seven grants to stimulate development of pediatric medical devices


September 23, 2013
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FDA approval expands access to artificial heart valve for inoperable patients

FDA issues final guidance on mobile medical apps

La FDA expide guía final sobre las aplicaciones médicas móviles


September 20, 2013
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U.S. Marshals seize food products at two Virginia food companies

FDA finalizes new system to identify medical devices

La FDA finaliza nuevo sistema para identificar los dispositivos médicos


September 19, 2013
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FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science


September 18, 2013
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Federal judge approves consent decree against Shamrock Medical Solutions Group


September 16, 2013
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FDA approves first generic capecitabine to treat colorectal and breast cancers

FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert


September 13, 2013
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New medical device treats urinary symptoms related to enlarged prostate


September 11, 2013
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FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines

La FDA aprueba el uso de Botox Cosmetic para mejorar la apariencia de las patas de gallo


September 10, 2013
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FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics

La FDA anuncia cambios en el etiquetado de seguridad y requisitos de estudios de mercado para los analgésicos opioides de liberación y acción prolongada


September 06, 2013
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FDA approves Abraxane for late-stage pancreatic cancer

Federal judge grants FDA request for consent decree with Idaho farm


September 03, 2013
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Federal judge approves consent decree against Dakota Laboratories


August 21, 2013
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New test system identifies 193 different yeasts and bacteria known to cause illness


August 16, 2013
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FDA reminds health care providers not to use sterile products from NuVision Pharmacy


August 12, 2013
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FDA approves new drug to treat HIV infection

La FDA aprueba nuevo medicamento para el tratamiento de la infección de VIH


August 12, 2013
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FDA awards contract to develop promising new technology to test radiation countermeasures


August 11, 2013
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FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding


August 11, 2013
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FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies


August 02, 2013
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FDA defines “gluten-free” for food labeling

La FDA define el término "sin gluten" para el etiquetado de alimentos


July 31, 2013
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FDA announces a voluntary recall of Nova Max Blood Glucose Test Strips

La FDA anuncia retiro voluntario de tiras de prueba de sangre para la glucosa de Nova Max


July 26, 2013
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FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement

FDA takes step to help ensure the safety of imported food

La FDA toma medidas para ayudar a garantizar la seguridad de los alimentos importados

La FDA prend des mesures pour veiller à la sécurité des aliments importés

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July 25, 2013
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FDA permits marketing of first U.S. test labeled for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin


July 23, 2013
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La FDA advierte a las compañías que deben suspender la venta ilegal de tratamientos para la diabetes

FDA alerts companies to stop illegal sale of treatments for diabetes

La FDA invita al público a dar su opinión sobre el mentol en los cigarrillos

FDA invites public input on menthol in cigarettes


July 15, 2013
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FDA permits marketing of first brain wave test to help assess children and teens for ADHD

La FDA permite la comercialización del primer examen de ondas cerebrales para evaluar el trastorno de déficit de atención e hiperactividad en niños y adolescentes


July 12, 2013
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FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization

FDA approves new treatment for a type of late-stage lung cancer

FDA proposes “action level” for arsenic in apple juice

La FDA propone "nivel de acción" para el arsénico en el jugo de manzana


July 09, 2013
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FDA, Justice Department takes action against Vermont dairy farm


June 29, 2013
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FDA to detain pomegranate seeds offered for import from Goknur of Turkey


June 28, 2013
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FDA approves the first non-hormonal treatment for hot flashes associated with menopause

La FDA aprueba el primer tratamiento no hormonal para sofocos asociados con la menopausia

Federal judge enters consent decree with Med Prep Consulting


June 27, 2013
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FDA approves first recombinant coagulation factor IX that is specifically indicated for routine use in preventing bleeding episodes (prophylaxis)

La FDA toma medidas para proteger a los consumidores de medicamentos peligrosos vendidos por farmacias virtuales ilegales

FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies


June 25, 2013
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FDA announces first decisions on new tobacco products through the substantial equivalence pathway

La FDA anuncia las primeras decisiones para regular los nuevos productos de tabaco a través de la vía de equivalencia sustancial


June 21, 2013
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FDA approves Vibativ for hospitalized patients with bacterial pneumonia

FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers


June 20, 2013
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DOJ News Release: The Department of Justice Files Suit Against Louisiana Pharmaceutical Company for Distributing Unapproved and Misbranded Prescription and Over-the-counter Drugs

FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential

La FDA aprueba anticonceptivo de emergencia Plan B One-Step para uso sin receta médica de todas las mujeres en edad fértil

FDA approves first genotyping test for patients with hepatitis C virus

La FDA aprueba el primer análisis de genotipo para pacientes con virus de hepatitis C


June 14, 2013
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La FDA aprueba un nuevo implante mamario de gel de silicona

FDA approves a new silicone gel-filled breast implant


June 13, 2013
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FDA approves Xgeva to treat giant cell tumor of the bone


May 29, 2013
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FDA approves two drugs, companion diagnostic test for advanced skin cancer

FDA announces import of injectable nutrition drugs

La FDA anuncia la importación de medicamentos inyectables para la nutrición


May 28, 2013
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FDA clears first blood tracking device that uses Radio Frequency Identification technology


May 24, 2013
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FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee


May 23, 2013
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FDA allows marketing of first A1c test labeled for diagnosing diabetes


May 18, 2013
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FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy


May 17, 2013
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FDA seeks preliminary injunction against New York fish manufacturer


May 15, 2013
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FDA approves Simponi to treat ulcerative colitis

La FDA aprueba nuevo medicamento para el cáncer de próstata avanzado

FDA approves new drug for advanced prostate cancer


May 14, 2013
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FDA approves Nymalize--first nimodipine oral solution for use in certain brain hemorrhage patients

FDA approves first companion diagnostic to detect gene mutation associated with a type of lung cancer


May 13, 2013
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FDA releases new tool to help prevent intentional food contamination


May 10, 2013
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FDA warns consumers about potential health risk with Juices Incorporated juice products

FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease


May 08, 2013
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FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop


May 06, 2013
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FDA issues proposal to increase consumer awareness of tanning bed risks

FDA warns pregnant women to not use certain migraine prevention medicines

La FDA advierte a mujeres embarazadas que no usen ciertos medicamentos para prevenir migrañas


April 30, 2013
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FDA approves Plan B One-Step emergency contraceptive without a prescription for females 15 years of age and older

FDA approves Procysbi for rare genetic condition


April 29, 2013
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FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding


April 24, 2013
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FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool

La FDA se asocia con otras organizaciones para la protección contra medicamentos antipalúdicos falsos a través del uso de un aparato portátil para la detección y desarrollado por la FDA


April 21, 2013
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FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy


April 16, 2013
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FDA approves abuse-deterrent labeling for reformulated OxyContin


April 15, 2013
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FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall

FDA: U.S. Marshals seize food at New York-based food facility


April 10, 2013
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FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical product safety


April 08, 2013
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La FDA aprueba Diclegis para las mujeres embarazadas que experimentan náuseas y vómitos

FDA approves Diclegis for pregnant women experiencing nausea and vomiting


March 29, 2013
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FDA approves Invokana to treat type 2 diabetes


March 27, 2013
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FDA approves new multiple sclerosis treatment: Tecfidera


March 22, 2013
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La FDA aprueba la primera antitoxina contra el botulismo para neutralizar todos los siete serotipos conocidos de la neurotoxina botulínica.

FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes

FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients

FDA issues proposal to improve the quality of automated external defibrillators


March 21, 2013
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FDA alerts health care providers and patients of the nationwide recall of all lots of sterile products distributed by Clinical Specialties Compounding Pharmacy


March 20, 2013
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FDA approves Dotarem, a new magnetic resonance imaging agent


March 18, 2013
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FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey

FDA warns consumers not to eat certain ProtiDiet High Protein Chocolate Dream Bars manufactured by Pro-Amino International, Inc., Quebec, Canada


March 13, 2013
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FDA approves Lymphoseek to help locate lymph nodes in patients with certain cancers

Federal judge approves consent decree with New Jersey bakery


March 08, 2013
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FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex


February 26, 2013
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La FDA aprueba Osphena para mujeres postmenopáusicas que sufren dolor durante el acto sexual

FDA approves Osphena for postmenopausal women experiencing pain during sex


February 25, 2013
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FDA approves Stivarga for advanced gastrointestinal stromal tumors


February 24, 2013
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FDA alerts health care providers of recall of anemia drug Omontys


February 22, 2013
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FDA enters into consent decree with Chicago sprout producer due to unsanitary conditions

La FDA aprueba un nuevo tratamiento para el cáncer de mama en etapa avanzada

FDA approves new treatment for late-stage breast cancer


February 21, 2013
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Kasel Associates Industries recalling certain pet treats due to Salmonella contamination


February 20, 2013
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FDA approves new silicone breast implant

FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events


February 14, 2013
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U.S. Marshals seize drug products distributed by a Florida company

La FDA aprueba el primer implante de retina para adultos con enfermedad ocular genética rara

FDA approves first retinal implant for adults with rare genetic eye disease


February 13, 2013
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FDA Commissioner Margaret A. Hamburg’s Statement on the Institute of Medicine’s Report “Countering the Problem of Falsified and Substandard Drugs”


February 08, 2013
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FDA approves Pomalyst for advanced multiple myeloma

Court shuts down U.S. operations of California drug, dietary supplement manufacturer


February 07, 2013
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FDA offers new guidance on developing drugs for Alzheimer’s disease


February 05, 2013
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The Nutrition Facts Label: Helping Americans Make Heart-Healthy Choices

La etiqueta de información nutricional: ayuda a la población a elegir opciones saludables para el corazón


February 04, 2013
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FDA approval of generic version of cancer drug Doxil is expected to help resolve shortage


February 01, 2013
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Michigan soy processor is under court order to meet FDA food safety standards

FDA approves new drug for the chronic management of some urea cycle disorders


January 31, 2013
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Federal judge approves consent decree with Ben Venue Laboratories


January 29, 2013
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FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder


January 28, 2013
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La FDA aprueba tres nuevos tratamientos farmacológicos para la diabetes tipo 2


January 25, 2013
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FDA approves three new drug treatments for type 2 diabetes

FDA: Fabricante de bebidas de Puerto Rico acepta decreto por consentimiento

FDA approves Gleevec for children with acute lymphoblastic leukemia

FDA: Puerto Rico beverage manufacturer enters into consent decree

FDA approves over-the-counter Oxytrol for Women to treat overactive bladder


January 23, 2013
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FDA approves Exjade to remove excess iron in patients with genetic blood disorder


January 18, 2013
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FDA approves Botox to treat overactive bladder


January 17, 2013
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FDA approves Octaplas to treat patients with blood clotting disorders


January 16, 2013
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FDA approves new seasonal influenza vaccine made using novel technology


January 11, 2013
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FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis

La FDA exige reducir la dosis recomendada para ciertos medicamentos para dormir que contienen zolpidem


January 10, 2013
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FDA requiring lower recommended dose for certain sleep drugs containing zolpidem


January 09, 2013
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FDA issues draft guidance on abuse-deterrent opioids


January 04, 2013
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La FDA propone nuevas normas de seguridad alimentaria para la prevención de enfermedades transmitidas por alimentos y la inocuidad de los productos agrícolas

FDA proposes new food safety standards for foodborne illness prevention and produce safety


December 31, 2012
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FDA approves first anti-diarrheal drug for HIV/AIDS patients

FDA approves first drug to treat multi-drug resistant tuberculosis


December 28, 2012
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FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation


December 26, 2012
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FDA approves new orphan drug for rare cholesterol disorder


December 21, 2012
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Federal judge enters order imposing restrictions on Sunland Inc.

FDA approves Varizig for reducing chickenpox symptoms

FDA expands Tamiflu’s use to treat children younger than 1 year

FDA approves Gattex to treat short bowel syndrome


December 20, 2012
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Invacare signs consent decree to correct wheelchair manufacturing problems


December 19, 2012
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FDA permits marketing of device to seal lung punctures


December 18, 2012
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FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery


December 14, 2012
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FDA approves Signifor, a new orphan drug for Cushing’s disease

FDA approves raxibacumab to treat inhalational anthrax

FDA approves Iclusig to treat two rare types of leukemia


December 10, 2012
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FDA expands Zytiga’s use for late-stage prostate cancer


December 06, 2012
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FDA warns consumers not to feed certain Nature’s Deli Chicken Jerky Dog Treats


December 03, 2012
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FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies


November 29, 2012
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FDA approves Cometriq to treat rare type of thyroid cancer


November 20, 2012
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FDA approves first seasonal influenza vaccine manufactured using cell culture technology

Federal judge approves consent decree with Minnesota drug and dietary supplement company

FDA approves pump for heart failure patients awaiting heart transplant


November 15, 2012
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FDA approves first drug-eluting stent to treat peripheral arterial disease


November 06, 2012
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FDA approves Xeljanz for rheumatoid arthritis


November 05, 2012
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FDA warns Tennessee company that online product claims violate federal law


November 02, 2012
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FDA expands use of Xarelto to treat, reduce recurrence of blood clots


October 31, 2012
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FDA reports voluntary recall of all Ameridose drug products


October 26, 2012
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FDA reports conditions observed at New England Compounding Center facility

FDA approves Synribo for chronic myelogenous leukemia


October 25, 2012
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Federal judge grants permanent injunction against Oregon herb and supplement manufacturer

FDA enters consent decree with New York dietary supplement manufacturer, Venus Pharmaceuticals


October 23, 2012
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Dietary supplements, unapproved drugs seized in New York


October 22, 2012
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FDA approves Fycompa to treat seizures


October 19, 2012
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FDA expands approved use of Sapien artificial heart valve


October 18, 2012
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FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes


October 04, 2012
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La FDA toma medidas contra miles de farmacias virtuales ilegales

FDA takes action against thousands of illegal Internet pharmacies


September 28, 2012
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FDA approves first subcutaneous heart defibrillator

FDA approves Humira to treat ulcerative colitis

FDA campaign aims to protect consumers from the risks of fake online pharmacies

La FDA lanza campaña para proteger a los consumidores de los riesgos de las farmacias virtuales falsas


September 27, 2012
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FDA approves new treatment for advanced colorectal cancer


September 24, 2012
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New FDA task force will support innovation in antibacterial drug development


September 22, 2012
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FDA advises consumers not to eat Trader Joe’s Valencia Creamy Salted Peanut Butter

El FDA aconseja a los consumidores no consumir la Mantequilla de Cacahuete Salada Cremosa Valencia de Trader Joe’s


September 20, 2012
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La FDA publica datos preliminares sobre los niveles de arsénico en los productos derivados del arroz y el arroz


September 19, 2012
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FDA releases preliminary data on arsenic levels in rice and rice products


September 18, 2012
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FDA approves first breast ultrasound imaging system for dense breast tissue

La FDA publica una alerta de seguridad relacionada con la Intestinomicina, un medicamento comercializado para el tratamiento de la diarrea infecciosa

FDA issues Safety Alert on Intestinomicina, drug product marketed as treatment for infectious diarrhea


September 14, 2012
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La FDA advierte a los consumidores sobre el riesgo de consumir mangos de Agrícola Daniella de México

FDA warns consumers against eating mangoes from Agricola Daniella of Mexico


September 12, 2012
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FDA approves new multiple sclerosis treatment Aubagio

FDA approves production of imaging agent that helps detect prostate cancer


September 06, 2012
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FDA issues warning letters to dietary supplement firms in Colorado and Texas for promoting unapproved products as drugs


September 04, 2012
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FDA approves new orphan drug for chronic myelogenous leukemia


August 31, 2012
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FDA approves new treatment for a type of late stage prostate cancer


August 30, 2012
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FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation


August 29, 2012
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FDA approves new treatment for severe neutropenia in certain cancer patients

FDA approves first drug formulated for children with rare brain tumor


August 27, 2012
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La FDA aprueba una nueva píldora de combinación para el tratamiento del VIH en algunos pacientes

FDA approves new combination pill for HIV treatment for some patients


August 23, 2012
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La FDA anuncia el retiro del mercado de melones de Chamberlain Farms de Owensville, Indiana


August 22, 2012
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FDA announces recall of cantaloupe by Chamberlain Farms of Owensville Indiana

FDA: U.S. Marshals seize food products at Fremont, Calif., warehouse


August 21, 2012
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La FDA emite una nueva advertencia de seguridad sobre Reumofan Plus y Reumofan Plus Premium

FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium


August 17, 2012
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FDA approves first generic Actos to treat type 2 diabetes


August 16, 2012
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FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment


August 15, 2012
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FDA warns of risk of death from codeine use in some children following surgeries


August 13, 2012
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FDA approves vaccines for the 2012-2013 influenza season


August 10, 2012
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FDA approves Lucentis to treat diabetic macular edema


August 09, 2012
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FDA approves Marqibo to treat rare type of leukemia


August 08, 2012
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FDA revises safety information and limits use of Stryker Wingspan brain stent system


August 03, 2012
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FDA approves first generic versions of Singulair to treat asthma, allergies

FDA approves Zaltrap for metastatic colorectal cancer


August 01, 2012
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Food Safety Guides for Groups Most Vulnerable to Foodborne Illness Now Available


July 30, 2012
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FDA warns consumers not to eat cantaloupes from Burch Equipment LLC of North Carolina
July 23, 2012
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FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease

FDA: More than 150 antiretroviral drugs available through PEPFAR for worldwide HIV/AIDS relief


July 20, 2012
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FDA warns consumers not to eat shellfish from Oyster Bay Harbor, Nassau County, NY

FDA approves Afinitor for advanced breast cancer

FDA approves Kyprolis for some patients with multiple myeloma


July 18, 2012
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Aprueba la FDA el medicamento Qsymia para bajar de peso


July 17, 2012
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FDA approves weight-management drug Qsymia

La FDA aprueba el primer medicamento para reducir el riesgo de infeccion del VIH adquirido sexualmente

FDA approves new colon-cleansing drug for colonoscopy prep


July 16, 2012
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FDA approves first drug for reducing the risk of sexually acquired HIV infection


July 13, 2012
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La FDA alerta a los consumidores sobre peligro de listeria en productos de la compania Mexicali Cheese Corp.

FDA seeks to halt production, distribution of dietary supplements at NY company

FDA warns consumers about Listeria threat in Mexicali Cheese Corp. products


July 12, 2012
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FDA outlines plans to provide earlier feedback on device product submissions

FDA, UC Davis, Agilent Technologies and CDC to create publicly available food pathogen genome database


July 10, 2012
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Wisconsin livestock dealer enters into consent decree involving drug residues in cows


July 09, 2012
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FDA introduces new safety measures for extended-release and long-acting opioid medications


July 06, 2012
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FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy


July 05, 2012
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FDA approves first DNA test to help manage CMV infection in organ transplant patients


July 04, 2012
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FDA prompts companies to remove certain unapproved oxycodone products from market


July 03, 2012
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FDA proposes unique device identification system for medical devices


June 28, 2012
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FDA approves Myrbetriq for overactive bladder


June 27, 2012
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La FDA aprueba Belviq para tratar a algunos adultos con sobrepeso u obesos

FDA approves Belviq to treat some overweight or obese adults

FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections


June 25, 2012
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FDA approves first glaucoma stent for use with cataract surgery


June 15, 2012
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Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)

La FDA aprueba una nueva vacuna combinada que protege a los niños contra dos enfermedades bacterianas


June 14, 2012
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FDA urges that oysters, clams, mussels, and some types of scallops from Korea should be removed from the market

FDA approves new combination vaccine that protects children against two bacterial diseases


June 08, 2012
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FDA approves Perjeta for type of late-stage breast cancer


June 06, 2012
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U.S. Marshals seized misbranded drugs in Maine


June 01, 2012
__________________

La FDA hace una advertencia sobre Reumofan Plus

FDA issues alert on Reumofan Plus


May 29, 2012
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FDA warns consumers about counterfeit version of Teva's Adderall


May 22, 2012
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FDA-led research team discovers an autoimmune mechanism for serious drug-induced adverse reactions

U.S. Marshals seize unapproved new drug from Crescendo Therapeutics LLC


May 17, 2012
__________________

FDA approves generic versions of blood thinner Plavix


May 15, 2012
__________________

FDA expands use for FilmArray Respiratory Panel


May 10, 2012
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FDA issues alert on potential dangers of unproven treatment for multiple sclerosis


May 09, 2012
__________________

FDA proposal aims to help reduce unnecessary radiation exposure for children


May 03, 2012
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FDA issues final rule on sterility testing of biological products


May 01, 2012
__________________

FDA permits marketing of a new device for abdominal surgery

FDA approves new orphan drug to treat a form of Gaucher disease


April 27, 2012
__________________

FDA approves new antibacterial treatment for plague

FDA approves Stendra for erectile dysfunction

FDA challenges marketing of DMAA products for lack of safety evidence


April 26, 2012
__________________

FDA approves Votrient for advanced soft tissue sarcoma

FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease

FDA Statement on USDA Announcement of Positive BSE Test Result


April 23, 2012
__________________

FDA strengthens international collaboration to ensure quality, safety of imported products


April 21, 2012
__________________

Report: FDA strengthens monitoring of post-approval drug safety


April 20, 2012
__________________

FDA issues draft guidance on nanotechnology


April 18, 2012
__________________

U.S. Marshals seize ultrasound gel product at a New Jersey company


April 13, 2012
__________________

La compañía Moon Marine USA Corporation retira voluntariamente del mercado el producto de atún de aleta amarilla crudo congelado

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product


April 11, 2012
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Dept. of Justice enters consent decree with California seafood processor

La FDA toma medidas para proteger la salud pública

FDA takes steps to protect public health


April 10, 2012
__________________

FDA approves imaging drug Amyvid


April 09, 2012
__________________

La FDA dicta decreto por consentimiento con productor de queso debido a contaminación por Listeria

FDA enters consent decree with cheese producer due to Listeria contamination

FDA announces plans to pilot end-stage kidney disease technology in new program


April 05, 2012
__________________

La FDA advierte a los consumidores a no comer galletas y pan tostado de marca Crispy fabricado por TWI Foods Inc., Ontario, Canadá

FDA warns consumers not to eat Crispy brand cookies and rusk manufactured by TWI Foods Inc., Ontario, Canada


March 30, 2012
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El gobierno del Presidente Obama toma medidas para enfrentar la epidemia de consumo de tabaco

Obama administration takes action to address tobacco epidemic


March 29, 2012
__________________

U.S. Marshals seize unapproved and misbranded drug products at Missouri distributor

FDA pursues enforcement action against California fish processor

FDA to discuss risks and benefits of metal-on-metal hip replacements


March 27, 2012
__________________

FDA approves additional blood test for viruses linked to leukemia, neurologic diseases

FDA approves Omontys to treat anemia in adult patients on dialysis

New FDA guidance on considerations used in device approval, de novo decisions


March 22, 2012
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FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease


March 19, 2012
__________________

FDA approves first Boniva generics to treat or prevent osteoporosis


March 16, 2012
__________________

FDA proposes lower risk classification for certain tuberculosis tests


March 14, 2012
__________________

FDA approves first generic Lexapro to treat depression and anxiety disorder


March 09, 2012
__________________

La FDA aprueba nuevos implantes de seno rellenos de gel de silicona

FDA approves new silicone gel-filled breast implant

FDA approves first cell-based product to treat oral mucogingival conditions in adults


March 08, 2012
__________________

FDA Commissioner Margaret A. Hamburg's Statement on the Surgeon General's Report


March 06, 2012
__________________

FDA approves Surfaxin to prevent breathing disorder in premature infants

FDA issues warning letter to makers of AeroShot “caffeine inhaler”


March 01, 2012
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FDA approves two new pancreatic enzyme products to aid food digestion


February 29, 2012
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FDA approves first quadrivalent vaccine to prevent seasonal influenza


February 28, 2012
__________________

FDA reaches $1 million settlement with Pennsylvania medical device firm

La FDA anuncia modificaciones relacionadas con la seguridad en las indicaciones de algunos medicamentos que reducen el colesterol

FDA announces safety changes in labeling for some cholesterol-lowering drugs


February 24, 2012
__________________

FDA approves first Helicobacter pylori breath test for children


February 22, 2012
__________________

Federal government gains permanent injunction against raw milk producer


February 21, 2012
__________________

FDA acts to bolster supply of critically needed cancer drugs


February 17, 2012
__________________

FDA approves Korlym for patients with endogenous Cushing’s syndrome


February 14, 2012
__________________

FDA approves Zioptan to treat elevated eye pressure


February 13, 2012
__________________

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply

New Jersey company agrees to halt production of unapproved dental devices


February 09, 2012
__________________

FDA investigating illegal online sale of handheld dental X-ray units

FDA issues draft guidance on biosimilar product development


February 01, 2012
__________________

FDA and industry reach agreement in principle on medical device user fees


January 31, 2012
__________________

FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

FDA approves Kalydeco to treat rare form of cystic fibrosis

FDA takes action against New York cheese manufacturer


January 30, 2012
__________________

FDA approves new treatment for most common type of skin cancer


January 27, 2012
__________________

FDA approves Inlyta to treat patients with a type of advanced kidney cancer


January 25, 2012
__________________

Department of Justice files Consent Decree of Permanent injunction against Ranbaxy


January 24, 2012
__________________

Maine company holds cold smoked salmon product after FDA order


January 20, 2012
__________________

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri


January 17, 2012
__________________

FDA approves Voraxaze to treat patients with toxic methotrexate levels


January 13, 2012
__________________

FDA completes work on three drug user fee programs


January 04, 2012
__________________

FDA to protect important class of antimicrobial drugs for treating human illness


December 30, 2011
__________________

FDA expands use of Prevnar 13 vaccine for people ages 50 and older


December 29, 2011
__________________

FDA to approve shared system REMS for TIRF products


December 22, 2011
__________________

FDA: Chicago-area sandwich manufacturer agrees to stop production


December 21, 2011
__________________

FDA expands use of HIV drug Isentress to children and adolescents

FDA: Do not use ShoulderFlex Massager


December 20, 2011
__________________

FDA collaboration to monitor rare eye condition associated with cataract surgery


December 16, 2011
__________________

FDA approves mechanical cardiac assist device for children with heart failure

FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies


December 14, 2011
__________________

FDA Statement on the Institute of Medicine Report: Scientific Standards for Studies on Modified Risk Tobacco Products


December 13, 2011
__________________

FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull

FDA issues Warning Letters for misleading advertising of Lap-Band


December 06, 2011
__________________

FDA: U.S. Marshals seize products containing banned ephedrine for dietary supplements

FDA announces changes to risk strategy requirements for 2 drugs to treat low platelet counts

FDA, FTC act to remove “homeopathic” HCG weight loss products from the market


December 01, 2011
__________________

FDA: U.S. Marshals seize dietary supplements, drugs manufactured by Syntec Inc.

FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals


November 30, 2011
__________________

FDA approves first generic version of cholesterol-lowering drug Lipitor


November 23, 2011
__________________

FDA takes enforcement action against Pennsylvania dietary supplement maker

FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep


November 21, 2011
__________________

FDA permits marketing of a system to repair failed, problematic fix for aortic aneurysms


November 18, 2011
__________________

FDA warns consumers not to eat one batch of Loyd Grossman Korma Sauce

FDA approves first supplemental test for Chagas disease

FDA Commissioner announces Avastin decision

FDA approves Erwinaze to treat a form of leukemia


November 16, 2011
__________________

FDA Statement on the International Tobacco Regulators' Conference

FDA approves first drug to treat a rare bone marrow disease


November 10, 2011
__________________

FDA approves first cord blood product

FDA issues two draft guidance documents to facilitate investigational medical device studies in humans

FDA acts to protect children from illegal tobacco sales


November 08, 2011
__________________

FDA Statement on Makena

FDA launches website on safe disposal of used needles and other “sharps”


November 07, 2011
__________________

FDA approves Erbitux to treat late-stage head and neck cancer


November 04, 2011
__________________

FDA warns consumers not to eat Bio Gaudiano brand Organic Olives Stuffed with Almonds

FDA warns consumers not to eat certain ASSI Brand frozen oysters

FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm


November 03, 2011
__________________

FDA: 35 innovative new drugs approved in fiscal year 2011


November 02, 2011
__________________

FDA approves first artificial aortic heart valve placed without open-heart surgery

FDA approves system to repair abdominal aneurysms in people with small arteries


November 01, 2011
__________________

FDA Enters Consent Decree of Permanent Injunction in NY Tissue Residue Case


October 28, 2011
__________________

FDA warns consumers not to eat Wegmans’ bulk Turkish pine nuts


October 26, 2011
__________________

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation


October 24, 2011
__________________

FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder

FDA approves Onfi to treat severe type of seizures


October 18, 2011
__________________

FDA: U.S. Marshals seize food products at Illinois warehouse


October 17, 2011
__________________

FDA proposes lower risk classification, special controls for external pacemakers


October 14, 2011
__________________

FDA approves Ferriprox to treat patients with excess iron in the body


October 11, 2011
__________________

FDA: U.S. Marshals seize foods stored at Washington State facility


October 07, 2011
__________________

FDA approves combination therapy Juvisync

FDA, CMS launch pilot program for voluntary parallel review of innovative devices


October 06, 2011
__________________

FDA approves Cialis to treat benign prostatic hyperplasia

FDA and NIH announce joint study on tobacco use and risk perceptions


October 05, 2011
__________________

FDA commissioner outlines steps to spur biomedical innovation, improve health of Americans


October 04, 2011
__________________

FDA approves gel to stop blood flow during blood vessel surgery

FDA Outlines Plans for an Outside Network of Scientific Experts


October 03, 2011
__________________

FDA awards three grants to stimulate development of pediatric medical devices

FDA works to improve science used to approve medical devices

FDA: New transparency report outlines proposals for enforcement data, for public comment


September 30, 2011
__________________

FDA seeks comment on streamlined review of lower risk, new technology, devices


September 29, 2011
__________________

FDA participates in global efforts to protect consumers and patients from unsafe drugs on the internet


September 28, 2011
__________________

FDA enters consent decree of permanent injunction against Florida drug companies

FDA clears first single use face mask for children


September 26, 2011
__________________

FDA Warns Consumers Not to Eat Raw Oysters Harvested from Hood Canal Area 4 in Washington State


September 23, 2011
__________________

FDA approves Remicade to treat ulcerative colitis in children older than 6 years

FDA approves Soliris for rare pediatric blood disorder


September 21, 2011
__________________

FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011


September 19, 2011
__________________

FDA confirms Listeria monocytogenes on Jensen Farms’ Rocky Ford-brand cantaloupes


September 14, 2011
__________________

FDA warns consumers not to eat Rocky Ford Cantaloupes shipped by Jensen Farms

FDA establishes foodborne illness outbreak response network

FDA: Minnesota companies agree to halt sale of amino-acid products with unapproved claims


September 13, 2011
__________________

FDA investigates multistate outbreak of listeriosis


September 12, 2011
__________________

FDA announces changes in drug center’s oncology office


September 10, 2011
__________________

FDA warns consumers of botulism risk in La Ruche tapenade, spreadable tomato paste


September 07, 2011
__________________

FDA: Pilot projects to explore ways to trace sources of foodborne illness


September 06, 2011
__________________

FDA announces new staff training for medical device reviewers


August 31, 2011
__________________

FDA Commissioner Margaret A. Hamburg’s Statement on the Passing of Dr. Charles Edwards


August 26, 2011
__________________

FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer

FDA hurricane preparedness checklist


August 25, 2011
__________________

FDA: U.S. Marshals seize food products held at North Carolina warehouse

FDA requests seizure of adulterated seafood at California company

La FDA trabaja con México para proteger la inocuidad de las papayas importadas

FDA approves Firazyr to treat acute attacks of hereditary angioedema

FDA working with Mexico to protect safety of imported papayas


August 24, 2011
__________________

FDA approves Botox to treat specific form of urinary incontinence


August 19, 2011
__________________

FDA approves Adcetris to treat two types of lymphoma


August 17, 2011
__________________

FDA: Regulatory science plan positions agency to foster innovation through better science

FDA approves Zelboraf and companion diagnostic test for late-stage skin cancer


August 15, 2011
__________________

FDA seeks comment on proposed guidelines for high-quality clinical studies

FDA proposes guidelines that clarify benefit-risk determinations for medical devices


August 12, 2011
__________________

FDA, state of Arkansas sign agreement to advance regulatory science


August 03, 2011
__________________

FDA approves the first specific treatment for scorpion stings


August 02, 2011
__________________

FDA, international counterparts report progress on drug inspection collaboration

FDA reopens comment period on proposed ‘gluten-free’ food labeling rule


July 29, 2011
__________________

FDA to seek public comment on IOM recommendations


July 28, 2011
__________________

Unapproved emergency birth control medicine possibly in U.S. distribution may be ineffective and unsafe


July 26, 2011
__________________

FDA issues draft guidance on device changes that warrant new premarket review


July 25, 2011
__________________

Foodborne outbreak potentially associated with papaya distributed by Agromod Produce, Inc.

FDA Center for Drug Evaluation and Research develops strategic science and research agenda


July 20, 2011
__________________

FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes

FDA, federal partners develop tools for food-emergency readiness


July 19, 2011
__________________

FDA outlines oversight of mobile medical applications


July 18, 2011
__________________

FDA approves vaccines for the 2011-2012 influenza season


July 16, 2011
__________________

Foodborne outbreak associated with raw milk from Tucker Adkins Dairy of York S.C.


July 13, 2011
__________________

FDA: Surgical placement of mesh to repair pelvic organ prolapse poses risks


July 12, 2011
__________________

FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies


July 08, 2011
__________________

FDA approves Boostrix to prevent tetanus, diphtheria, and pertussis in older people


July 07, 2011
__________________

FDA proposes new policy for some diagnostic and radiology devices


July 05, 2011
__________________

FDA approves Xarelto to reduce risk of blood clots after hip, knee replacements

FDA issues anti-smuggling strategy and draft guidance on new dietary ingredients


July 01, 2011
__________________

FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease

FDA, Justice Department take action against California calf hauler

 

 

 

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