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 ...
JD Supra

New FDA approval process promotes development of rare disease gene therapies

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...
Hosted on MSN

FDA Publishes Drug Filing Checklists, Issues First-Ever Emergency Use for Animal Drug

WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the ...
RAPS

FDA Guidance Sets Up Voluntary New IDE Submission Process Aimed at Correcting Deficiencies

US regulators today released a new draft guidance document that looks to clarify the US Food and Drug Administration's (FDA) expectations when it comes to approving an investigational device exemption ...
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 ...