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NIH Shuts Down Drug Making Operation Due to FDA Findings

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The National Institutes of Health Clinical Center shuts down operations at its Pharmaceutical Development Section after serious ma...

CA Court Allows Essure Cases to Proceed

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A California state court allows a series of product liability lawsuits to proceed against Bayer by 14 women who allege that they h...

FDA Confirms Date for Updated Biological Standards

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Federal Register Direct final rule: FDA confirms the effective date of a 5/4 final rule amending the general biological products s...

Hospira Recalls 1 Lot of Bupivacaine Anesthesic

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Pfizers Hospira drug unit recalls one lot of 0.25% bupivacaine hydrochloride injection, USP due to the presence of particulate mat...

FDA Keeps Flowcharts in New Draft Guidance on Device Modifications

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FDA keeps its popular flowcharts in a new draft guidance that updates recommendations on when device makers need to submit a new 5...

Drager Recalls Leaky Pediatric Patient Breathing Circuit

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Drger begins a Class 1 recall of its VentStar Oxylog 3000 Pediatric Patient Breathing Circuit after it was discovered that the che...

FDA Panel Backs Egalet Abuse Deterrent Pain Drug

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A joint FDA advisory committee votes 18 to 1 to recommend that an Egalet NDA for Arymo ER (morphine sulfate extended-release table...

Input Requested on Down Classifying Certain Class 3 Devices

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FDA seeks comments on a final set of PMA product codes that have been identified under a two-year retrospective review as candidat...

CBER Panel to Hear Research Updates

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Federal Register Notice: FDA plans a meeting via teleconference of the Cellular, Tissue, and Gene Therapies Advisory Committee 9/7...

Workshop Planned on Pediatric Master Protocols

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Federal Register Notice: FDA schedules a public workshop 9/23 on pediatric master protocols and clinical trial design consideratio...