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Biotechnology › Draft Guidance › Over The Counter Drugs (OTC)

Sheppard Mullin Richter & Hampton LLP

New Accelerated Approval Guidance Underscores Need for Accountability

Sheppard Mullin Richter & Hampton LLP on

On December 5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more

Arnall Golden Gregory LLP

The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs

Arnall Golden Gregory LLP on

The Food and Drug Administration let sponsors and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more

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