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Comments Sought on Disease Progression Models

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Federal Register notice: FDA seeks comments on an upcoming workshop on advancing model-informed drug development.

Pfizer Tick-Borne Encephalitis Vaccine BLA

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FDA accepts for priority review a Pfizer BLA for TicoVac, its tick-borne encephalitis vaccine for use in individuals one year of a...

FDA Denies Sun Pharma Taclantis CRL Appeal

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FDA denies Sun Pharmas appeal of a complete response letter for its Taclantis NDA and asks for a new Phase 3 study.

FDA Raises Covid-19 Compounded Drug Concerns

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FDA voices its specific concerns with compounded drugs being used to treat patients with Covid-19.

Takeaways from FDA Monograph Reform Webinar

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Attorney Carolina Wirth says a recent FDA Webinar on monograph reform included timeframes that indicate reform will take several y...

Guide on Testing Alcohols for Methanol

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Federal Register notice: FDA posts a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Met...

Comments on Antimicrobial Drugs Used in Feed

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Federal Register notice: FDA extends the comment period on a 1/11 notice requesting comments regarding a document entitled Potenti...

Info Collection on Biologic Adverse Event Reports

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Federal Register notice: FDA sends to OMB an information collection extension for Adverse Experience Reporting for Licensed Biolog...

OPDP Cites Misleading Paragard Consumer Video

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The CDER Office of Prescription Drug Promotion warns CooperSurgical that a Paragard promotional video fails to communicate any ris...

FDA Denies Synergy Pharmaceuticals Linzess Petition

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FDA denies a Synergy Pharmaceuticals petition asking that it order Forest Laboratories to make changes to the Linzess prescribing ...