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FDA OKs First Priority ANADA for Horses

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Federal Register Notice: FDA approves a First Priority ANADA for veterinary prescription use of phenylbutazone tablets in horses.

FDA Says Fentanyl Transdermal Shortage Resolved

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FDA says that a previous market shortage involving fentanyl transdermal patch products has been resolved.

FDA Warns About FDA Impersonators

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FDA says callers claiming to be FDA special agents or other officials are scamming consumers who believe they are buying discounte...

FDA Considering Bisphosphonate Study

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FDA says it continues to monitor reports of atrial fibrillation in patients taking bisphosphonates and is considering additional r...

Advisors to Consider Embeda Risk

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Two FDA advisory committees are considering whether including an antagonist in an extended-release morphine capsule is sufficient ...

Q&A on Production and Process Controls

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CDER and CBER issue a question-and-answer guidance on production and process controls.

Info on CGMPs for Blood/Components Sent To OMB

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Federal Register Notice: FDA sends a proposed collection of information on CGMPs for blood and blood components and requirements f...

Civil Money Penalties Adjusted

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Federal Register Proposed rule: FDA plans to amend its regulations to adjust the maximum civil money penalty amounts for inflation...

FDA Approves Trial of Celgene Stem Cell Therapy

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FDA says Celgene Cellular Therapeutics may conduct a Phase 1 trial of its investigation immunomodulatory therapy using human place...

J&J-Merck Recall Infant Mylicon Drops

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Johnson & Johnson-Merck Consumer Pharmaceuticals Company recalls about 12,000 units of Infants' Mylicon Gas Relief Dye-free Drops.