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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...

Quality, Reporting Problems at Power Interventions

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FDAs Philadelphia District Office warns Power Medical Interventions over quality and medical device reporting violations at its ma...

FDA OKs Focalin 30-min Onset of Action Claim

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FDA approves a 30-minute onset of action labeling claim for Novartis ADHD drug Focalin XR extended-release capsules.

Obama Team Starting Agency Review

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Obama transition team members are heading into federal agencies amid anonymous comments suggesting a major shake-up to rid FDA of ...

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...