WASHINGTON, Nov. 26 -- Food and Drug Administration has issued a notice called: Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Nov. 26 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Cross-Center Master Files: Where to Submit." The draft guidance provides recommendations to industry, specifically master file holders, regarding where ( i.e, to which FDA center) to submit a master file that is referenced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 ...