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Petition Urges FDA to Ease Oversight of Stem Cell Products

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A biotechnology company specializing in adult-derived stem cells urges FDA to relax federal regulation of some regenerative therap...

FDA, USP, and Industry Convene to Boost Drug Quality

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FDA joins the United States Pharmacopeia and the Association for Accessible Medicines next month for a public workshop focused on ...

What FDA Might Want in Chatbot Therapy for Depression

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Orrick attorneys say discussions at an FDA Digital Health Advisory Committee meeting indicate the agency intends to adopt oversigh...

FDA OKs Companion Diagnostic for Endometrial Cancer Therapy

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FDA approves Promegas OncoMate MSI Dx Analysis System as a companion diagnostic for identifying endometrial carcinoma patients who...

FDA Unveils Plausible Mechanism Approval Pathway

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FDA introduces a new regulatory framework the plausible mechanism pathway designed to speed approval of highly personalized ther...

Repeat CGMP Issues at Miers Laboratories

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FDA warns New Zealands Miers Laboratories about repeat CGMP violations in its manufacturing of finished drugs.

Neurocrines NMDA Modulator Fails Phase 2 in Depression

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Neurocrine Biosciences reports that its Phase 2 study of NBI-1070770, an investigational NMDA receptor modulator for major depress...

Complying with QMSR Critical Business Strategy: Attorneys

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Alston & Bird attorneys urge medical device companies to move quickly to prepare to implement FDAs new Quality Management System R...

enGene Reports 62% Response Rate for Gene Therapy

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enGene says Phase 2 data showed that its gene therapy detalimogene voraplasmid produced a 62% complete response rate at six months...

CGMP Violations at Taizhou Kangping

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FDA warns Chinas Taizhou Kangping Medical Science and Technology Co. about CGMP violations in its manufacturing of over-the-counte...