FDA accepts proposal for reasonably likely surrogate endpoint for ‘MASH’ all-cause mortality or liver-related events

FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

CGMP/Finished Pharmaceuticals/Adulterated

Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).

Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL).

October 28, 2025, Vanguard Enterprises, LLC. DBA Bedrock MFG of Boise, Idaho is recalling Monarch Premium Kratom brand Bali Gold, Red Bali, Green Maeng Da, and White Elephant powder because product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometime