The revised draft guidance from the US Food and Drug Administration (FDA) on drug master files (DMFs) deals with submissions on confidential information about facilities, manufacturing, processing, ...
The US Food and Drug Administration (FDA) has released new draft guidance on how it assesses the completeness of drug master files submitted to it under generic drug applications, aiming to streamline ...
DMF No. 43568 is now active and available for reference in global IND and NDA submissions CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that ...