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FDA Issues OTC Drug Delivery Device Guidance

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FDA issues a draft guidance on markings placed on drug delivery devices packaged with OTC liquid drug products.

Obama Losing at FDA, Too

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FDA Webview editor Jim Dickinson sees the same disappointment gap in promised Obama changes at FDA as the voters saw more generall...

InterMune Submits Pirfenidone NDA

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InterMune submits an NDA to FDA for pirfenidone to treat idiopathic pulmonary fibrosis.

American Regent Expands Ketorolac Recall

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American Regent recalls all lots of ketorolac tromethamine injection 15 mg/ML.

FDA Field Laboratories Safe Or Are They?

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Consulting editor John Scharmann reports on a year-long hiatus in plans to close FDA field laboratories, but says the threat remai...

Hamburg Launches Safe Use Initiative for Drugs

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Commissioner Margaret Hamburg announces the agencys Safe Use Initiative, a cooperative effort to involve health care workers and c...

Panel Recommends Rejecting Zimmer Spine Device

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FDAs Orthopedic and Rehabilitation Devices Advisory Panel recommends that FDA reject a new indication for Zimmer Spines Dyneses Sp...

FDA Posts Device Cybersecurity Reminder

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FDA reminds medical device manufacturers and users of their shared obligation to maintain cybersecurity for devices.

GenVec Drug for Pancreatic Cancer Gets 'Orphan' OK

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FDA grants GenVec, Inc.s TNFerade orphan drug and fast-track designation for treating pancreatic cancer.

FDA Grants Priority Review to Shires Gaucher Disease Therapy

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FDA grants priority review to Shires NDA for velaglucerase alfa to treat Type 1 Gaucher disease.