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Device Postmarket Surveillance Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Postmarket Surveillance of Medical Devices ...

Info Collection on FOIA Identity Certifications

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Federal Register notice: FDA seeks comments on an information collection extension entitled Certification of Identity; Form FDA 39...

BioMarin Asked to Submit New Data on Gene Therapy

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BioMarin Pharmaceutical says FDA is requesting results from an upcoming three-year data analysis from the ongoing Phase 3 GENEr8-1...

Califf Comes Down With Covid-19

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FDA commissioner Robert Califf tests positive for Covid-19 while traveling over the weekend on agency business.

Guide on Early Studies on Cell/Gene Therapies

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Federal Register notice: FDA makes available a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Pr...

Guide on Bioanalytical Method Validation

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Federal Register notice: FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.

GSK Blenrep Phase 3 Misses Primary Endpoint

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A Phase 3 trial of GSKs accelerated-approved Blenrep (belantamab mafodotin) in patients with relapsed or refractory multiple myelo...

FDA Places Hold on Verve Hypercholesterolemia Drug

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FDA slaps a clinical hold on a Verve Therapeutics IND for its VERVE-101 in patients with heterozygous familial hypercholesterolemi...

Verrica Pharma Refiling NDA for VP-102

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Verrica Pharmaceuticals says it is filing an NDA resubmission in the first quarter next year for VP-102 to treat molluscum contagi...