Food & Drug Administration Issues Notice of Availability on ANDAs: Pre-Submission Facility Guidance
June 16, 2025
June 16, 2025
WASHINGTON, June 16 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a notice of availability (Docket No. FDA-2017-D-3101) entitled "Abbreviated New Drug Applications: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions; Guidance for Industry; Availability."
This notice announces the availability of a final guidance document for the industry. The guidance details the facility information . . .
This notice announces the availability of a final guidance document for the industry. The guidance details the facility information . . .