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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...

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.

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...

Europe Rules Against Amgens Tavneos Marketing Authorization

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While Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended th...

Regeneron Halts Phase 1/2a Eye Disease Trial Due to Safety Review

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Regeneron Pharmaceuticals stops a Phase 1/2a clinical trial of experimental anti-CD3 monoclonal antibody REGN7041 in patients with...

Senators Release 2021 Woodcock Email on Covid-19 Concern

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Sens. Ron Johnson (R-WI) and Rand Paul (R-KY) release a 2021 email from then-acting FDA commissioner Janet Woodcock in which she r...