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HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions

USA - January 12 2021 On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection...

David Horowitz.

Final FDA combination product guidance encourages application-based feedback pathways

USA - December 14 2020 The U.S. Food and Drug Administration (FDA) recently finalized its guidance entitled “Requesting Food and Drug Administration Feedback on Combination...

David M. Fox, Randy Prebula.

Comment period ending for proposal to automatically sunset HHSFDACMS regulations

USA - November 19 2020 The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a...

David Horowitz, Stuart M. Langbein, Philip Katz, Randy Prebula.

A step in the right direction: Encouraging diversity in clinical trial populations

USA - November 12 2020 On November 9, 2020, the U.S. Food and Drug Administration (FDA) released a final version of its guidance, Enhancing the Diversity of Clinical Trial...

Blake E. Wilson, Robert Church, Eman Al-Hassan.

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

USA - October 25 2020 Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing...

Meredith Manning, Susan S. Lee.