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Libby Laboratories CGMP Issues

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FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.

Device AI Facts Labeling Needed: Paper

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University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered...

New FDA Guide Doesnt Stop Some Device Hacking: Paper

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A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices...

Biotech Leaders Support Access to Mifepristone

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A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to r...

FDA Drops REMS Need for ERA Meds

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FDA drops REMS requirements covering embryofetal toxicity risk in endothelin receptor antagonists.

CGMP Violations at Exela Pharma Sciences

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FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.

Support for Biosimilar Legislation

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Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the ...

FDA Prodded to Improve Surrogate Endpoint Transparency

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A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to incr...

Taiho Reports Unfavorable DMD Drug Data

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Taiho Pharmaceutical reports disappointing data from its Phase 3 extension study of TAS-205 (pizuglanstat) in patients with Duchen...

FDA Urged to Expand Real-World Data Use

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A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety a...