FDA News Digest   Search our archive and pharma company websites…                                                                              Search Tools…   News Search | Generic Drug Companies | Company Name | API | Pharma Stocks | News - Archive Latest Press Releases Our Archive… May 17, 2013 __________________ FDA seeks preliminary injunction against New York fish manufacturer May 15, 2013 __________________ 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 __________________ 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 __________________ FDA releases new tool to help prevent intentional food contamination May 10, 2013 __________________ 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 __________________ FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop May 06, 2013 __________________ 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 __________________ 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 __________________ FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding April 24, 2013 __________________ 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 __________________ FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy April 16, 2013 __________________ FDA approves abuse-deterrent labeling for reformulated OxyContin April 15, 2013 __________________ 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 __________________ FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical product safety April 08, 2013 __________________ 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 __________________ FDA approves Invokana to treat type 2 diabetes March 27, 2013 __________________ FDA approves new multiple sclerosis treatment: Tecfidera March 22, 2013 __________________ 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 __________________ 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 __________________ FDA approves Dotarem, a new magnetic resonance imaging agent March 18, 2013 __________________ 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 __________________ 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 __________________ FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex February 26, 2013 __________________ 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 __________________ FDA approves Stivarga for advanced gastrointestinal stromal tumors February 24, 2013 __________________ FDA alerts health care providers of recall of anemia drug Omontys February 22, 2013 __________________ 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 __________________ Kasel Associates Industries recalling certain pet treats due to Salmonella contamination February 20, 2013 __________________ FDA approves new silicone breast implant FDA seeks input on minimizing disruptions to medical device supply chain during extreme weather events February 14, 2013 __________________ 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 __________________ 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 __________________ FDA approves Pomalyst for advanced multiple myeloma Court shuts down U.S. operations of California drug, dietary supplement manufacturer February 07, 2013 __________________ FDA offers new guidance on developing drugs for Alzheimer’s disease February 05, 2013 __________________ 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 __________________ FDA approval of generic version of cancer drug Doxil is expected to help resolve shortage February 01, 2013 __________________ 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 __________________ Federal judge approves consent decree with Ben Venue Laboratories January 29, 2013 __________________ FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder January 28, 2013 __________________ La FDA aprueba tres nuevos tratamientos farmacológicos para la diabetes tipo 2 January 25, 2013 __________________ 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 __________________ FDA approves Exjade to remove excess iron in patients with genetic blood disorder January 18, 2013 __________________ FDA approves Botox to treat overactive bladder January 17, 2013 __________________ FDA approves Octaplas to treat patients with blood clotting disorders January 16, 2013 __________________ FDA approves new seasonal influenza vaccine made using novel technology January 11, 2013 __________________ 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 __________________ FDA requiring lower recommended dose for certain sleep drugs containing zolpidem January 09, 2013 __________________ FDA issues draft guidance on abuse-deterrent opioids January 04, 2013 __________________ 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 __________________ FDA approves first anti-diarrheal drug for HIV/AIDS patients FDA approves first drug to treat multi-drug resistant tuberculosis December 28, 2012 __________________ FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation December 26, 2012 __________________ FDA approves new orphan drug for rare cholesterol disorder December 21, 2012 __________________ 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 __________________ Invacare signs consent decree to correct wheelchair manufacturing problems December 19, 2012 __________________ FDA permits marketing of device to seal lung punctures December 18, 2012 __________________ FDA warns against improper advertising, promotion of lasers intended for LASIK corrective eye surgery December 14, 2012 __________________ 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 __________________ FDA expands Zytiga’s use for late-stage prostate cancer December 06, 2012 __________________ FDA warns consumers not to feed certain Nature’s Deli Chicken Jerky Dog Treats December 03, 2012 __________________ FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies November 29, 2012 __________________ FDA approves Cometriq to treat rare type of thyroid cancer November 20, 2012 __________________ 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 __________________ FDA approves first drug-eluting stent to treat peripheral arterial disease November 06, 2012 __________________ FDA approves Xeljanz for rheumatoid arthritis November 05, 2012 __________________ FDA warns Tennessee company that online product claims violate federal law November 02, 2012 __________________ FDA expands use of Xarelto to treat, reduce recurrence of blood clots October 31, 2012 __________________ FDA reports voluntary recall of all Ameridose drug products October 26, 2012 __________________ FDA reports conditions observed at New England Compounding Center facility FDA approves Synribo for chronic myelogenous leukemia October 25, 2012 __________________ 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 __________________ Dietary supplements, unapproved drugs seized in New York October 22, 2012 __________________ FDA approves Fycompa to treat seizures October 19, 2012 __________________ FDA expands approved use of Sapien artificial heart valve October 18, 2012 __________________ FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes October 04, 2012 __________________ La FDA toma medidas contra miles de farmacias virtuales ilegales FDA takes action against thousands of illegal Internet pharmacies September 28, 2012 __________________ 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 __________________ FDA approves new treatment for advanced colorectal cancer September 24, 2012 __________________ New FDA task force will support innovation in antibacterial drug development September 22, 2012 __________________ 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 __________________ La FDA publica datos preliminares sobre los niveles de arsénico en los productos derivados del arroz y el arroz September 19, 2012 __________________ FDA releases preliminary data on arsenic levels in rice and rice products September 18, 2012 __________________ 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 __________________ 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 __________________ FDA approves new multiple sclerosis treatment Aubagio FDA approves production of imaging agent that helps detect prostate cancer September 06, 2012 __________________ FDA issues warning letters to dietary supplement firms in Colorado and Texas for promoting unapproved products as drugs September 04, 2012 __________________ FDA approves new orphan drug for chronic myelogenous leukemia August 31, 2012 __________________ FDA approves new treatment for a type of late stage prostate cancer August 30, 2012 __________________ FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation August 29, 2012 __________________ 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 __________________ 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 __________________ La FDA anuncia el retiro del mercado de melones de Chamberlain Farms de Owensville, Indiana August 22, 2012 __________________ 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 __________________ 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 __________________ FDA approves first generic Actos to treat type 2 diabetes August 16, 2012 __________________ FDA recommends X-ray or other imaging on implanted heart defibrillators with St. Jude Medical Riata leads to help guide treatment August 15, 2012 __________________ FDA warns of risk of death from codeine use in some children following surgeries August 13, 2012 __________________ FDA approves vaccines for the 2012-2013 influenza season August 10, 2012 __________________ FDA approves Lucentis to treat diabetic macular edema August 09, 2012 __________________ FDA approves Marqibo to treat rare type of leukemia August 08, 2012 __________________ FDA revises safety information and limits use of Stryker Wingspan brain stent system August 03, 2012 __________________ FDA approves first generic versions of Singulair to treat asthma, allergies FDA approves Zaltrap for metastatic colorectal cancer August 01, 2012 __________________ Food Safety Guides for Groups Most Vulnerable to Foodborne Illness Now Available July 30, 2012 __________________ FDA warns consumers not to eat cantaloupes from Burch Equipment LLC of North Carolina July 23, 2012 __________________ 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 __________________ 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 __________________ Aprueba la FDA el medicamento Qsymia para bajar de peso July 17, 2012 __________________ 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 __________________ FDA approves first drug for reducing the risk of sexually acquired HIV infection July 13, 2012 __________________ 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 __________________ 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 __________________ Wisconsin livestock dealer enters into consent decree involving drug residues in cows July 09, 2012 __________________ FDA introduces new safety measures for extended-release and long-acting opioid medications July 06, 2012 __________________ FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy July 05, 2012 __________________ FDA approves first DNA test to help manage CMV infection in organ transplant patients July 04, 2012 __________________ FDA prompts companies to remove certain unapproved oxycodone products from market July 03, 2012 __________________ FDA proposes unique device identification system for medical devices June 28, 2012 __________________ FDA approves Myrbetriq for overactive bladder June 27, 2012 __________________ 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 __________________ FDA approves first glaucoma stent for use with cataract surgery June 15, 2012 __________________ 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 __________________ 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 __________________ FDA approves Perjeta for type of late-stage breast cancer June 06, 2012 __________________ 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 __________________ FDA warns consumers about counterfeit version of Teva's Adderall May 22, 2012 __________________ 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 __________________ 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 __________________ 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 __________________ 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 __________________ 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 __________________ 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 __________________ FDA approves two new pancreatic enzyme products to aid food digestion February 29, 2012 __________________ 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       View Earlier News   © 2013 Betterchem.com