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FDA Proposes to Improve Veterinary Feed Directive Program

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Federal Register Proposed rule: FDA proposes to amend its animal drug regulations on veterinary feed directive drugs to improve th...

FDA Warns Burzynski About Research Violations

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FDA warns Burzynski Research Institute about its failure to follow clinical research requirements and protect human subjects.

FDA Still Has Dapagliflozin Questions

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FDA medical reviewers say they cant be certain from updated study information that Bristol-Myers Squibbs diabetes drug dapaglifloz...

FDA Seeks to Phase-out Antimicrobials in Food Animals

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FDA asks antimicrobial drug manufacturers to revise their labels under a voluntary plan to help phase out human-use antibiotics in...

FDA Seeks OTC Topical Anesthetic Labeling Changes

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FDA asks for labeling changes in all OTC topical antiseptic drug products indicated for preoperative or pre-injection skin prepara...

Cerdelga to Get Priority Review for Gaucher Disease

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FDA approves a six-month priority review for Genzymes NDA for Cerdelga to treat adult patients with Gaucher Disease Type 1.

CSL Behring Opposes Berinert, Cinryze Petition

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CSL Behring tells FDA it opposes a citizen petition asking the agency to impose new safety measures on Berinert and Cinryze.

Federal Budget Deal Frees Up Sequestered User Fees

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Advamed praises a bipartisan federal budget deal that would release user fees that were caught up in the sequestration and repeal ...

Orexigen Re-files NDA for Weight-loss Drug

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Orexigen Therapeutics resubmits its NDA for weight-loss drug Contrave (naltrexone/bupropion) after reporting last month a positive...

FDA Clears Ethicon Surgical Shears

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FDA clears an Ethicon Endo-Surgery 510(k) for its Harmonic Focus+ Shears with Adaptive Tissue Technology for use in several surgic...