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FDA Challenged to Keep Up With ALS Therapies

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Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace ...

Drop Rabbit Pyrogen Test References: Petition

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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

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

Cingulate Gets FDA Complete Response Letter on ADHD Drug

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FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...

Early Alert on Abiomed Introducer Kits Due to Serious Injuries

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FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...

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...