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Comments Reopened on Good Clinical Practice Guide

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Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.

Priority Review for DMD Cardiomyopathy BLA

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FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy c...

Zenrelia Promotions False and Misleading: FDA

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FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representati...

FDA Safety Alert on Immune Globulin Products

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An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products...

Merck Reports Positive Data on HIV Trials

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Merck says it will seek FDA approval for new HIV regimen following its announcement of positive results from two pivotal Phase 3 t...

Beckman Coulter 510(k) Cleared for Clinical Analyzer

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FDA clears a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer.

CGMP Deviations at Shree Jaya Unit

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FDA warns Indias Shree Jaya Laboratories about CGMP deviations in its production of active pharmaceutical ingredients at a facilit...

Linghai ZhanWang Records Show CGMP Violations

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FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.

Positive Data on Pfizer/Arvinas Breast Cancer Study

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Pfizer and Arvinas announce positive topline results from a clinical trial evaluating vepdegestrant monotherapy versus fulvestrant...

FDA Rejects All Mid-Link Technology Data

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FDA tells Chinas Mid-Link Technology Testing Co. it is rejecting all data from all studies conducted by the company until it provi...