Senior Regulatory Counsel

0910-AH50 201810 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Biologics License Applications and Master Files

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deems any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020. Some of the affected NDAs were approved using drug master files (DMFs). A DMF, or other master file, allows an applicant to incorporate proprietary information from another manufacturer into its application by reference to the master file. BLAs generally may not rely on drug substance, drug substance intermediate, or drug product information contained in master files. The proposed rule would permit the contained use of DMFs for NDAs subject to the BPCI Act transition.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 601.2 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263 42 U.S.C. 263a 42 U.S.C. 264 Pub. L. 111–148, title VII, sec. 7002(e), Mar. 23, 2010, 124 Stat. 817 No NPRM 10/00/2018 No No None No No No No Anuj Shah Senior Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-2246 anuj.shah@fda.hhs.gov Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 6224, Silver Spring MD 20993