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HHS/FDA | RIN: 0910-AH50 | Publication ID: Spring 2018 |
Title: Biologics License Applications and Master Files | |
Abstract:
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. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 601.2 | |
Legal Authority: 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 |
Legal Deadline:
None |
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Timetable:
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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 | |
Agency Contact: Anuj Shah 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 Phone:301 796-2246 Email: anuj.shah@fda.hhs.gov |