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Drop Rabbit Pyrogen Test References: Petition

[ Price : $8.95]

Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit th...

FDA Orders Takeda to Add Boxed Warning to Adzynma

[ Price : $8.95]

FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition o...

FDA Names Veteran Investigator as Head of Inspections/Investigations

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FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency...

Fulcrum Therapeutics Halts Sickle Cell Disease Program

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Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving fe...

CBER Post New E-Submission Frequently Asked Questions Guide

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FDA posts a new set of frequently asked questions (FAQ) aimed at helping companies navigate the electronic submission process for ...

Be Prepared for New One-Day FDA Inspections: Law Firms

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Law firms Hogan Lovells and Foley and Lardner advise pharmaceutical and medical device companies to maintain full inspection readi...

Former FDA and HHS Heads Opine on Next Commissioner

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Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson urge policymakers to prioritize leader...

Report Urges FDA Overhaul for Faster Reviews

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A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical de...

Guide on Reducing Animal Studies for Cancer Products

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FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conj...

ICH Q&A Document for Drug Quality Guidelines

[ Price : $8.95]

ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines.