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FDA Proposed Rule Changes Facility Registration

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Two Argent Fox Schiff attorneys describe an FDA proposed rule that would change how some drug manufacturers register their facilit...

FDA Panel Backs Replimune Melanoma Therapy

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FDAs Cellular, Tissue, and Gene Therapies Advisory Committee votes to recommend approval of Replimune's experimental oncolytic imm...

Sen. Johnson Wants Covid Interviews with Former FDAers, Fauci

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Sen. Ron Johnson asks to interview four former CBER officials and Anthony Fauci on the safety and efficacy of Covid vaccines.

Rybrevant Faspro sBLA Gets Priority Review for Head & Neck Cancer

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FDA accepts for priority review a Johnson & Johnson supplemental BLA for subcutaneous Rybrevant Faspro for adults with recurrent o...

Cerovene Cited for Repeat Manufacturing and Data Integrity Deficiencies

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FDA cites contract drug manufacturer Cerovene Inc. for repeat current good manufacturing practice deficiencies following a recent ...

Ways to Overcome Cancer Trial Site Activation Bottlenecks: Research

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A Friends of Cancer Research survey report documents bottlenecks in U.S. oncology clinical trial site scale-up activation and sugg...

Gasco Industrial Cited for Repeat Manufacturing Deficiencies

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FDA issues Gasco Industrial Corp. a Form 483 for significant and repeat GMP deficiencies following a 2/17-27 inspection of the com...

PolyPid NDA Accepted for Preventing Surgical Site Infection

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FDA accepts for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections in patients undergoing ...

FDA Posts User Fee Rates for FY 2027

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FDA posts the following user fee rates for medical product programs for fiscal year 2027.

9 Items on Bentley Laboratories FDA-483

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FDA releases the form FDA-483 with nine observations from an inspection at the Edison, NJ-based Bentley Laboratories over-the-coun...