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Drug Experiential Learning Site Visits for FY 2025

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Federal Register notice: FDA announces its fiscal year 2025 CDER Office of Pharmaceutical Quality Experiential Learning Site Visit...

Accelerated Approval for Novartis Fabhalta

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FDA gives accelerated approval to Novartis Fabhalta for reducing proteinuria in primary IgA nephropathy.

Huxley Gains Clearance for At-Home Apnea Test

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FDA clears a Huxley Medical 510(k) for at-home sleep apnea diagnostic patch, Sansa.

Panel to Review Urinary Tract Infection NDA

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Federal Register notice: FDA announces a 9/9 Antimicrobial Drugs Advisory Committee meeting to discuss an Iterum Therapeutics NDA ...

OTC Monograph Admin Order Comments Extended

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Federal Register notice: FDA reopens the comment period for its proposed administrative order entitled Amending Over-the-Counter M...

FDA to Survey Healthcare Providers

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The CDER Office of Prescription Drug Promotion releases plans to survey 2,400 healthcare providers on several issues relating to p...

Servier Gets OK for Brain Tumor Drug

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FDA approves a Servier Pharmaceuticals NDA for Voranigo (vorasidenib) for treating certain adult and pediatric patients 12 years a...

Data Integrity is Biggest Inspection Issue: FDA

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CDER compliance officer Yasamin Ameri says FDA will issue about the same number of drug CGMP Warning Letters in 2024 as in 2023.

Enforce Regulation of Wellness Devices: Petition

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Spark Biomedical, a manufacturer of an FDA-approved neurostimulation device, asks the agency to ensure that unapproved neurostimul...

FDA Cites Krazati Provider Web Page

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The CDER Office of Prescription Drug Promotion says a Mirati Therapeutics provider Web page for Krazati makes false and misleading...