Zdrowie i gospodarka · 29/05/2026

FDA Releases Final Guidance on Bioequivalence Studies for ANDA Submissions

The FDA has released a final guidance for industry on conducting bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an Abbreviated New Drug Application (ANDA), providing recommendations for applicants and finalizing a draft guidance issued in 2021.

Source: Federal Register — Health and Human ServicesOpen original release →

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Zdrowie i gospodarka · 10/9/2026

Center for Scientific Review Notice of Closed Meetings

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Zdrowie i gospodarka · 10/5/2026

CDC Invites Public Comment on Proposed Data Collection for Public Health Crisis Response

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Zdrowie i gospodarka · 10/5/2026

CDC Requests Public Comment on Respiratory Protective Devices Data Collection

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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

CDC Invites Public Comment on Proposed Data Collection for Public Health Emergency Preparedness

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