Zdrowie i gospodarka · 07/01/2025

FDA Releases Draft Guidance on Accelerated Approval and Confirmatory Trials

The FDA has released a draft guidance outlining its interpretation of 'underway' for confirmatory trials of drugs granted accelerated approval, aiming to clarify policies for implementing this requirement.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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Zdrowie i gospodarka · 10/9/2026

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Zdrowie i gospodarka · 10/5/2026

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Zdrowie i gospodarka · 10/5/2026

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Zdrowie i gospodarka · 10/5/2026

Federal Agencies Review Forms Under the Paperwork Reduction Act

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Zdrowie i gospodarka · 10/5/2026

Center for Scientific Review Amends Meeting Notice

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Zdrowie i gospodarka · 9/28/2026

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