|View EO 12866 Meetings||Printer-Friendly Version Download RIN Data in XML|
|HHS/FDA||RIN: 0910-AH50||Publication ID: Spring 2020|
|Title: 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. FDA’s longstanding policy is that BLAs generally may not rely on drug substance, drug substance intermediate, or drug product information contained in master files.
The final rule will permit the contained use of DMFs for NDAs subject to the BPCI Act transition.
The final rule will codify that a biological product that was originally approved as a new drug application under the FD&C Act can continue to reference a DMF for drug substance, a drug substance intermediate, or a drug product information after the application is deemed to be a license under the PHS Act.
The final rule also codifies FDA’s existing practice that a BLA may not otherwise rely on a master file for information concerning a drug substance, a drug substance intermediate, or a drug product except in the investigational phase of the application under an investigational new drug application. The final rule also clarifies that the non-biological constituent part(s) of a combination product regulated under a BLA may rely on any information in a DMF.
|Agency: Department of Health and Human Services(HHS)||Priority: Substantive, Nonsignificant|
|RIN Status: Previously published in the Unified Agenda||Agenda Stage of Rulemaking: Final Rule Stage|
|Major: No||Unfunded Mandates: No|
|EO 13771 Designation: Deregulatory|
|CFR Citation: 21 CFR 601.2|
|Legal Authority: 42 U.S.C. 262 42 U.S.C. 321 (et seq.) Pub. L. 111–148, title VII sec. 7002(e), Mar. 23, 2010, 124 Stat. 817|
|Regulatory Flexibility Analysis Required: No||Government Levels Affected: None|
|Small Entities Affected: No||Federalism: No|
|Included in the Regulatory Plan: No|
|RIN Data Printed in the FR: No|
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, WO 51, Room 6224,
Silver Spring, MD 20993