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FDA May Go Months Without Senate-Confirmed Commissioner: Analysis

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An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hu...

Diamantas Touts FDA Moves to Boost U.S. Jobs

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FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American ...

FDA Selects Dexcom as First Participant in Digital Health Pilot with CMS

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FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pil...

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 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...