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Guidance on Skin Irritation Studies for Transdermal/Topical ANDAs

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FDA issues a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritati...

FDA Expands Pluvicto Approval to Earlier-Stage Prostate Cancer

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FDA approves Novartis' Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with androgen receptor pathway inhibitor (A...

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...

Argon Medical Convenience Kit Correction is Class I Recall

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FDA classifies a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associate...

New FDA Flexibility in Cell and Gene Therapy Approvals

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A BioProcess International column praises a new FDA final guidance for introducing some flexibilities into approval of cell and ge...

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...