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Shaver Permanently Debarred by FDA

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Jonathan R. Shaver from providing services in any capacity to a...

FDA Debars Smith for 5 Years

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Federal Register notice: FDA issues an order debarring Richard B. Smith III for five years from importing or offering for import a...

Emerging Drug Safety Technology Meeting Program

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CDER Office of Surveillance and Epidemiology deputy director Robert Ball describes the Emerging Drug Safety Technology Meeting pro...

DSCSA Pilot Project Report Out

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FDA says it has issued a final report from the Drug Supply Chain Security Act pilot project.

ICH M10 Bioanalytical Method Analysis Q&A Guidance

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FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioana...

FDA Accelerated Approval for BMS Augtyro Cancer Drug

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FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyr...

Megadyne Recalls Pediatric Return Electrodes

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Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned du...

Submit Long Covid Drug as IND: FDA

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FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.

Drug Distribution Security Comment Period Reopened

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Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better unders...

Info Collection on Drug Compounding

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Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, a...