Withdrawn - Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research; Draft Guidance for Industry

The guidance document entitled "Draft Guidance for Industry - Submitting Type V Drug Master Files to the Center for Biologics Evaluation and Research" was withdrawn on August 9, 2010. Additional information is available on CBER's web site (https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/new-drug-application-nda-and-abbreviated-new-drug-application-anda-cber-regulated-products).

If you have any questions about submitting drug master files to the Center for Biologics Evaluation and Research, please contact the Office of Communication, Outreach and Development toll-free at 1-800-835-4709 (toll 301-827-1800) or by email at matt@fda.hhs.gov.