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FDA, Industry Getting Closer to MDUFA Reauthorization

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Industry negotiators say the number of outstanding issues to be resolved with FDA as part of MDUFA 3 reauthorization talks is decr...

Advisors Support Prevnar Approval

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FDA advisors vote to recommend that Pfizers Prevnar pneumonia vaccine is safe and effective for use in adults over age 50.

FDA Proposes Regs on Tobacco Product Brand Names

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Federal Register Proposed rule: FDA proposes to amend regulations to allow certain tobacco manufacturers to maintain a brand name ...

Workshop on Using Naloxone to Reduce Opioid Fatalities

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Federal Register Notice: CDER will co-sponsor a public workshop on making naloxone widely available to reduce opioid overdose fata...

Panel to Discuss Post-surgery Ocular Drugs

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Federal Register Notice: FDAs Dermatologic and Ophthalmic Drugs Advisory Committee will meet 2/27/12 to discuss post-surgical opht...

Medtronic's AdaptiveStim Neurostimulator for Pain Approved

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FDA approves a Medtronic PMA for the AdaptiveStim with RestoreSensor neurostimulation system for treating chronic pain.

FDA Accepts NDA for Northera

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FDA accepts a Chelsea Therapeutics NDA for Northera (droxidopa), an orally active synthetic precursor of norepinephrine for treati...

FDA Requires Color Additive Labeling on Animal Food

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Federal Register Final rule: FDA amends its regulations on the declaration of certified color additives on the labels of animal fo...

Bill Would Broaden Generic Drug Marketing Exclusivity

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Sens. Bingaman and Vitter introduce legislation to expand generic drug marketing exclusivity to companies other than first filers.

After 50 Years, Animal Antibiotics Still a Waiting Game

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Consulting editor John Scharmann takes a critical look at FDAs 50-year-long hesitation to curb the growth-promotant, subtherapeuti...