Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Cross-Center Master Files: Where to Submit." The draft guidance provides recommendations to industry, specifically master file holders, regarding where (i.e., to which FDA center) to submit a master file that is referenced in and intended to support more than one regulatory submission for which the lead center for those submissions may vary or where the information in the master file may need to be accessed and reviewed by more than one center to support review of the referencing submission(s). The recommendations apply to master files submitted to the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), and certain types of master files submitted to the Center for Veterinary Medicine (CVM).