JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
C&EN

March 13 Policy Watch: FDA streamlines its process for approving biosimilar drugs

The US Food and Drug Agency announced on March 9 new guidelines for testing biosimilar products, biologic drugs that are made by someone other than the inventor. Whereas a generic-drug manufacturer ...
RAPS

FDA Finalizes Guidance on Priority Review Process for Medical Devices

Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document, ...
Morningstar

Sesh Products US Inc.'s Nicotine Pouch Bundled PMTA Advances to FDA Substantive Scientific Review Phase

Application Covering 64 SKUs Clears FDA Filing Review, Poised to Enter the Final Regulatory Phase Prior to a Marketing Order Decision Sesh Products US, Inc. (Sesh) today announced that the U.S. Food ...