News & Events
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2011 Press Announcements
October 2011
- October 07, 2011 - FDA approves combination therapy Juvisync
- October 07, 2011 - FDA, CMS launch pilot program for voluntary parallel review of innovative devices
- October 06, 2011 - FDA approves Cialis to treat benign prostatic hyperplasia
- October 06, 2011 - 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
- October 04, 2011 - FDA Outlines Plans for an Outside Network of Scientific Experts
- October 03, 2011 - FDA awards three grants to stimulate development of pediatric medical devices
- October 03, 2011 - FDA works to improve science used to approve medical devices
- October 03, 2011 - FDA: New transparency report outlines proposals for enforcement data, for public comment
September 2011
- 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
- September 28, 2011 - 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 6 years and older
- September 23, 2011 - 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
- September 14, 2011 - FDA establishes foodborne illness outbreak response network
- September 14, 2011 - 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 2011
- 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
- August 26, 2011 - FDA hurricane preparedness checklist
- August 25, 2011 - FDA: U.S. Marshals seize food products held at North Carolina warehouse
- August 25, 2011 - FDA requests seizure of adulterated seafood at California company
- August 25, 2011 - La FDA trabaja con México para proteger la inocuidad de las papayas importadas
- August 25, 2011 - FDA approves Firazyr to treat acute attacks of hereditary angioedema
- August 25, 2011 - 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
- August 17, 2011 - 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
- August 15, 2011 - 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
- August 02, 2011 - FDA reopens comment period on proposed ‘gluten-free’ food labeling rule
July 2011
- 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 28, 2011 - Evital no ha sido aprobado por la FDA para su uso en los Estados Unidos.
- 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.
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