FDA News Digest   Search our archive and pharma company websites…                                                                              Search Tools…   News Search | Generic Drug Companies | Company Name | API | Pharma Stocks | News - Archive 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   © 2011 Betterchem.com