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Guidance on Adhesion Testing for Generic Transdermal/Topical Drugs

[ Price : $8.95]

FDA finalizes a guidance outlining how generic drug developers should evaluate the adhesion performance of transdermal and topical...

Ziltivekimab Misses Endpoint in Cardiovascular Outcomes Trial

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Novo Nordisk says its investigational anti-inflammatory drug ziltivekimab failed to reduce the risk of major adverse cardiovascula...

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FDA issues a revised draft guidance updating its recommendations for how generic drug developers should evaluate the skin irritati...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

Draft Guidance on Biosimilar Container Closure Design

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A new FDA draft guidance outlines how sponsors should develop and evaluate container closure systems and device components used wi...

Commentary Questions FDA's Drug Innovation Policies

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A new Harvard Law School legal commentary argues that decades of policies designed to accelerate pharmaceutical innovation may hav...

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...

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...