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FDA Sets Digital Health Technologies A/C

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FDA says it will accept until 12/11 applications for its new Digital Health Technologies Advisory Committee.

Info Collection on Radiopharmaceuticals

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Federal Register notice: FDA seeks comments on an information collection entitled Regulations for In Vivo Radiopharmaceuticals Use...

Cell, Gene Therapy Success Rates Analyzed

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A Tufts Center for Biomedical System Design analysis says cell and gene therapies are more likely to be successful than other ther...

Breakthrough Devices Could Aid Disadvantaged: Attorneys

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Two Reed Smith attorneys explain how FDA may grant a breakthrough device designation to medical devices that have the potential to...

Senator Calls on FDA to Probe Respironics

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Sen. Richard Blumenthal (D-CT), in a second complaint, urges FDA to join the U.S. Department of Justice to thoroughly investigate ...

Former FDAer Beitz Joins Law Firm

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Hyman, Phelps & McNamara hires former CDER Office of Immunology and Inflammation director Julie Beitz as a principal drug regulato...

FDA Needs to Define Substantial Equivalence

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FDA Webview editor Jim Dickinson urges commissioner Robert Califf to begin rulemaking to establish a regulatory definition of subs...

Ozempic Kidney Study Stopped Due to Efficacy Data

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Positive efficacy data prompts Novo Nordisk to stop a kidney outcomes trial (FLOW) that was studying the effects of Ozempic (semag...

No Care Access Issues in VALOR Trial: Company

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Care Access says an FDA inspection cleared it of good clinical practice violations that had been alleged by Pfizer during its VALO...

Cytoxan Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that certain formulations of Baxter Pharmaceuticals Cytoxan (cyclophosphamide) for injecti...