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Panel on Opioid Overdose Studies

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Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studie...

AI in Regulatory Science: Conference Report

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A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligenc...

Digital Health Technologies an FDA Priority: Article

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Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.

Inspections Will Suffer Under FDA Cuts: Lawyers

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Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity coul...

Hill Staffer Graham Appointed to FDA Policy Office

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FDA appoints Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs.

FDA Wants Contractors to Replace Some Fired Staff

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FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have b...

2 Medical Device FAQs Issued

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FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse eve...

Celltrions Humira Biosimilar Now Interchangeable: FDA

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FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

Trump to FDA: Boost Generics, OTCs, Rx Imports

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A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and...

Petition Seeks GMP Amendment for Sampling Logbooks

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A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of...