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ICH Guide on Including Pregnant Women in Trials

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FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women i...

FDA Rejects Genentechs Bid to Expand Columvi Use

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FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.

Panel Votes Down Rexulti for PTSD

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FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when us...

FDA Mulls Pulling Sareptas Gene Therapy

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An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (deland...

CDER Losing Staff In Droves: Report

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An online post details a significant number of resignations from CDER in the first six months of this year.

Alert on B.Braun Microbore Extension Sets

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FDA issues an alert saying B. Braun Medical has notified customers recommending that certain microbore extension sets be removed f...

J&Js Bladder Cancer NDA Gets Priority Review

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FDA grants priority review to Johnson & Johnsons NDA for TAR-200 for treating patients with Bacillus Calmette-Gurin-unresponsive h...

pCR May Not be Valid Rectal Cancer Endpoint: Study

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A Tulane University researcher says FDAs use of pathologic complete response as a surrogate endpoint for rectal cancer treatments ...

FDA Looking to Expand Project Orbis Outside Oncology

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FDA Oncology Center of Excellence director Richard Pazdur says the agency and its international partners are considering expanding...

FDA AI Moves Raise Questions: Attorneys

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Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial inte...