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Regulatory Agenda › Draft Guidance › Over The Counter Drugs (OTC)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5, 2024, just in time for the holidays, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Expedited Program for Serious Conditions: Accelerated Approval of Drugs and...more

Sheppard Mullin Richter & Hampton LLP

FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software

Sheppard Mullin Richter & Hampton LLP on

On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the...more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The Room Where It Happens: FDA Issues Draft Guidance on Formal Meetings Between FDA and Sponsors of OTC Monograph Drugs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and requestors of over-the-counter (“OTC”) monograph drugs know how to be in the room where it happens when it issued a draft guidance this month on “Formal Meetings Between FDA...more

Mintz - Health Care Viewpoints

The Other Shoe Drops: FDA Withdraws 30-Year-Old Homeopathic Drug Enforcement Policy and Puts Industry on Notice of Further...

Mintz - Health Care Viewpoints on

To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more

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