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EUA Granted for Monkeypox Diagnsotic

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Federal Register notice: FDA issues an emergency use authorization for a Life Technologies in vitro diagnostic device for detectin...

Vaccine Advisors Angry at Lack of Transparency

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Some FDA and CDC vaccine advisors say they should have been given Moderna Covid booster infection data, even though it was early a...

We Agree: FDA Should Jettison Foods

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FDA Webview editor Jim Dickinson supports a Washington Post editorial board recommendation made after a meeting with the agencys l...

Criminal Probe Nets 2 Guilty Pleas Over Stolen Test Strips

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An FDA Office of Criminal Investigations probe leads to guilty pleas by Jennifer Robertson (Battle Creek, MI) and Michelle McAllis...

Many Recalled 510(k) Devices Had Recalled Predicates: Study

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Academic medical center researchers say a loophole in the law allows FDA to clear 510(k) submissions whose predicate was subject t...

Attorneys Look Back, Ahead at FDA

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SheppardMullin attorneys review FDA 2022 actions in several regulatory areas and look ahead to 2023.

CGMP Violations at Indias Sun Pharmaceutical

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FDA warns Sun Pharmaceuticals about CGMP violations and other issues in its production of finished drugs in Gujarat, India.

Model-Informed Drug Development Meetings Continue

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Federal Register notice: FDA announces the continuation of its Model-Informed Drug Development Paired Meeting Program as part of t...

Correction Notice on Advisory Committee Charter Renewal

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Federal Register notice: FDA corrects a 12/13/2022 notice entitled Advisory Committee; Cardiovascular and Renal Drugs Advisory Com...

Standardizing REMS Information in SPL

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CDER Office Medication Error Prevention and Risk Management director Claudia Manzo describes the change in REMS format to SPL.