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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 Sued for Generic Derma-Smoothe Approval

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Hill asks a federal court to order FDA to withdraw its approval of ANDAs for three generic Derma-Smoothe products.

FDA Finalizes Med Guide-only REMS Changes

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FDA finalizes a guidance that will allow the agency to circumvent heavy administrative burdens under its risk evaluation and minim...

Advisors Support Xifaxan Study Design

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Members of FDAs Gastrointestinal Drugs Advisory Committee say they support a Xifaxan clinical trial design developed by Salix and ...

First Drug for Equine Cushings Disease Approved

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FDA approves Boehringer Ingelheim Vetmedicas Prascend, the first drug to treat Cushings disease in horses.