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2014-08-29 23:10:24

Award Includes Operations and Maintenance in Support of CFSAN Reston, VA (PRWEB) August 29, 2014 The Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), awarded a five-year, single-award, indefinite delivery, indefinite quantity (IDIQ) contract and the first two task orders: “FARM V Operations and Maintenance” and “Development, Modernization and Enhancement (DME) for FARM VI” to the team of...

2014-08-29 23:09:31

On August 26, the FDA announced the recall of several sterile convenience surgical packs, by Customed Inc., due to possible loss of sterility. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 29, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on sterile convenience surgical packs. The US FDA...

2014-08-29 23:06:02

DEA’s announcement comes after a recommendation last year concerning the potent combination drug products. Port Washington, New York (PRWEB) August 29, 2014 Parker Waichman LLP, a national law firm that has long been dedicated to protecting the rights of victims who have been injured by medications reports that the Drug Enforcement Administration (DEA) has announced new regulations for all hydrocodone combination products. According to a Regulatory Affairs Professionals Society (RAPS)...

2014-08-28 23:15:55

For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and Quality Systems Regulation, information readers need to stay in compliance. Each monthly issue brings its readers updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions. Falls Church, VA (PRWEB) August 28, 2014 Subscribe to The GMP Letter...

2014-08-28 23:15:08

On August 1, New England Greens, LLC dba Vibrant Health announced that specific lots of Green Vibrance and one lot of Rainbow Vibrance are recalled because of possible health risk. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 28, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Green Vibrance...

2014-08-28 23:15:02

Learn how to navigate an advisory panel from an insider’s perspective. FDAnews has teamed Chris Sloan, Principal Consultant at Quintiles Consulting and former FDA device advisory panelist, and Michael Morton, Medtronic’s chief for global regulatory affairs, in a 90-minute presentation on the FDA advisory panel process. Falls Church, VA (PRWEB) August 28, 2014 FDA Device Advisory Panel Review Process: How to Ensure Successful Outcomes **FDAnews Webinar** Sept. 24, 2014 — 1:30 p.m....

2014-08-28 23:07:21

Millennium Treatment Group wants to make parents and loved ones aware of the dangers of powdered caffeine. Lake Worth, FL (PRWEB) August 28, 2014 Following the death of an 18-year-old high school senior in Ohio, on July 21, the FDA issued a warning on powdered caffeine products. Millennium Treatment Group is spreading the word about this harmful substance that is readily available to consumers, despite the fact that it is extremely dangerous. In May, high school senior Logan Stiner died...

2014-08-28 12:29:56

PITTSBURGH, Aug. 28, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration (FDA). This product is the generic version of Teva's Copaxone® 40 mg/mL, which is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS)....

2014-08-28 08:28:27

Represents First BLA Submission for a PCSK9 Inhibitor THOUSAND OAKS, Calif., Aug. 28, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for evolocumab seeking approval for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to...

2014-08-27 23:12:41

On August 1, Sunburst Superfoods announced that Organic Raw Carob Powder sold from March 12, 2014 through July 28, 2014 is recalled due to possible contamination with Salmonella. In light of this news, AttorneyOne, a recognized authority on law, updated the website providing detailed information to consumers. San Diego, CA (PRWEB) August 27, 2014 AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Organic Raw Carob...


Word of the Day
pungle
  • To take pains; labor assiduously with little progress.
This word comes from the Spanish 'pongale,' put it.
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