JD Supra

FDA Seeks Comments on Updates to MoCRA Guidance on Registration, Listing of Cosmetic Product Facilities

On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On ...
JD Supra

Time Flies! Cosmetic Manufacturing Facilities are Due for FDA Registration Renewal

Manufacturers and processors of U.S.-distributed cosmetic products must renew their facility registration for the first time by July 1, 2026. To assist with the biennial registration requirement, the ...
Orange County Register

Under Trump, FDA looks to abandon expert reviews of new drugs

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...

2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: Sept 24th - Sept ...

Market opportunities include gaining a comprehensive understanding of FDA procedures for US pharmaceutical submissions, critical for navigating the largest global market. This course provides deep ...

Cadrenal Therapeutics Announces End-of-Phase 2 Meeting with the FDA and Pivotal Phase 3 Registration Path for CAD-1005 in Heparin-Induced Thrombocytopenia (HIT)

FDA provided critical guidance for the advancement of CAD-1005 to pivotal Phase 3 in HIT Phase 2 data showed a greater than 25% absolute reduction in thrombotic events when CAD-1005 was added to ...
WholeFoods Magazine

House Dietary Supplement Listing Act Sparks Debate Over FDA Product Registry

A new House bill would require dietary supplement manufacturers to register products with FDA, reigniting debate between ...