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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

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FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus prevent...

Novo Nordisk Sues Lilly Over GLP-1 Ads

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Novo Nordisk sues Lilly in New Jersey federal court over what the company says is a misleading national ad campaign that compares ...

CGMP Issues at Indias Shimoga Chemicals

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FDA warns Indias Shimoga Chemicals about CGMP deviations in its production of active pharmaceutical ingredients.

No Informed Consent in Alembic Trial

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FDA warns Indias Alembic Research Center that it failed to obtain informed consent for an in vivo bioequivalence study.

Acadia Gets Fast Track for Alzheimers Psychosis Drug

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FDA awards Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A recepto...

Make Better Use of 505(b)(2) Pathway: Column

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Two InnoDev Partners consultants urge industry to re-embrace the 505(b)(2) approval pathway in instances in which it can save drug...

FDA Reform Requires a Whole-of-System Strategy: Editorial

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A Cureus Journal of Medical Science open-source editorial calls for a rebuilding of the U.S. scientific infrastructure as the only...

House Passes FDA Modernization Act 3.0 for Reducing Animal Testing

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The U.S. House of Representatives passes the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to a...

FDA, DoJ Expanding Enforcement Across Healthcare Ecosystem, Attorney Says

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In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are inc...

Opinion Piece Praises Diamantas' Vision for FDA Modernization

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A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emp...