News & Events
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2011 Press Announcements
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December 2011
- 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
- December 21, 2011 - 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
- December 16, 2011 - 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
- December 13, 2011 - FDA issues Warning Letters for misleading advertising of Lap-Band
- December 07, 2011 - Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step
- December 06, 2011 - FDA: U.S. Marshals seize products containing banned ephedrine for dietary supplements
- December 06, 2011 - FDA announces changes to risk strategy requirements for 2 drugs to treat low platelet counts
- December 06, 2011 - 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.
- December 01, 2011 - FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals
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November 2011
- 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
- November 23, 2011 - 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
- November 18, 2011 - FDA approves Eylea for eye disorder in older people
- November 18, 2011 - FDA approves first supplemental test for Chagas disease
- November 18, 2011 - FDA Commissioner announces Avastin decision
- November 18, 2011 - FDA approves Erwinaze to treat a form of leukemia
- November 18, 2011 - FDA Commissioner Removes Breast Cancer Indication from Avastin Label
- November 16, 2011 - FDA Statement on the International Tobacco Regulators' Conference
- November 16, 2011 - FDA approves first drug to treat a rare bone marrow disease
- November 10, 2011 - FDA approves first cord blood product
- November 10, 2011 - FDA issues two draft guidance documents to facilitate investigational medical device studies in humans
- November 10, 2011 - FDA acts to protect children from illegal tobacco sales
- November 08, 2011 - FDA Statement on Makena
- November 08, 2011 - 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
- November 04, 2011 - FDA warns consumers not to eat certain ASSI Brand frozen oysters
- November 04, 2011 - 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
- November 02, 2011 - 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
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October 2011
- 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
- October 24, 2011 - 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
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