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FDA Cautions Compounders on Bulk Sources

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FDA says drug compounders should be sure the active pharmaceutical ingredients and excipients they use have been evaluated by thei...

FDA Drug Inspections Slow to Recover: Analysis

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ProPublica says FDA foreign drug manufacturer inspections remain well below pre-pandemic inspection levels.

Guidance Shows Importance of Sponsor Oversight: Attorneys

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Sidley attorneys say a new FDA final guidance on a risk-based approach to clinical trial oversight is significant for trial sponso...

Generic Mifepristone Maker Sues FDA

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Generic mifepristone maker GenBioPro sues FDA to block the agency from taking any actions against the company if a pending court o...

FDA OKs Qulipta Expanded Indication

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FDA approves an expanded indication for AbbVies Qulipta to prevent chronic migraines.

High Court Adds 2 Days to Mifepristone Stay

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The U.S. Supreme Court extends by two days (until 4/21) its administrative stay of a lower courts 4/7 order that would restrict th...

EMA/FDA Bioequivalence Info Sharing Pact Adds Ireland

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An ongoing European Medicines Agency and FDA joint initiative on information sharing involving generic drug bioequivalence study i...

FDA OKs Traditional Approval for Genentechs Polivy

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FDA grants traditional approval of Genentechs Polivy (polatuzumab vedotin-piiq) for combination use with four other drugs in for t...

House Oversight Panel Puts Heat on FDA Over CBD

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House Committee on Oversight and Accountability chairman James Comer begins probe into FDAs recent decision not to regulate cannab...

Info Collection Extension on Cell/Tissue Products

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Federal Register notice: FDA announces an opportunity for public comments on an information collection extension entitled FDA Huma...