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CGMP Violations Found in Eugia Pharma Inspection

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FDA warns Indias Eugia Pharma about CGMP violations at its drug manufacturing facility in Kolthur Village.

Trump Picks Health Policy Adviser Overton as FDA Commissioner Nominee

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President Donald Trump selects White House health policy adviser Heidi Overton as his nominee to become FDA commissioner.

FDA Cites Neeyaan for Process Validation and Quality-System Failures

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FDA cites Neeyaan LLC for multiple GMP deficiencies, including the firms failure to validate drug manufacturing processes, conduct...

How Will FDA Regulate Vision Language Models?

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Mosaic Clinical Technologies petitions FDA to explain the regulatory principles it is applying to artificial intelligence vision l...

FDA Wants Feedback on Device GenAI Discussion Paper

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FDA asks for stakeholder responses to six discussion questions in a paper on regulating generative AI-enabled medical devices.

4 API Manufacturing Violations at Chinas Tianjin Kilo

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FDA warns Chinas Tianjin Kilo Pharmaceutical Sci-tech Co. about CGMP deviations the agency found in records it requested on the co...

McGuireWoods Narver Leaving Practice to Rejoin FDA

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McGuireWoods partner Clint Narver announces his departure from the law practice to rejoin FDA as director of the Office of Compoun...

Amylyx to File NDA Based on Positive Phase 3 Results for Avexitide

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Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide.

Valisure Sues USP Over Criticism of Drug-Testing Methods

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Valisure files a lawsuit against the United States Pharmacopeia, accusing the standards-setting organization of making false and m...

FDA Updates Guidance on Choosing Between ANDA and 505(b)(2) Pathways

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FDA posts a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted throu...