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FDA Rejects Gilead Hepatitis Delta BLA

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FDA issues Gilead a complete response letter on its BLA for bulevirtide, an investigational entry-inhibitor for treating adults wi...

C-Diff Drug Development Guide

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Federal Register notice: FDA makes available a draft guidance entitled Clostridioides difficile Infection: Developing Drugs for Tr...

4 Information Collections Approved by OMB

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Federal Register notice: FDA posts notifications that four information collections have been approved by OMB.

FDA Relaxes Promotion Restrictions on Covid EUAs

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FDA relaxes advertising and promotion restrictions placed on six Covid-19 emergency use authorizations.

Advanced Compounding Hit With FDA-483

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FDA posts a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this ...

Advisory Panel Shoots Down Y-mAbs BLA

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An FDA advisory committee unanimously votes to not recommend approval of a Y-mAbs Therapeutics BLA for I-omburtamab.

510(k) Addresses FDA Hemodialysis Machine Concerns

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FDA clears a Fresenius Medical 510(k) to implement changes to its 2008T hemodialysis machines that addresses an earlier FDA safety...

FDA Advancing Treatments for Children

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FDA officials list ways in which the agency is promoting the development of pediatric medicines.

FDA Questions Y-mAbs Neuroblastoma Treatment Efficacy

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FDA raises efficacy questions about a Y-mAbs BLA for I-omburtamab to treat pediatric patients with CNS/leptomeningeal metastases f...

Digital Health Regulatory Science Opportunities

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The CDRH Digital Health Center of Excellence releases a document highlighting topics of interest for regulatory science research a...