The "deemed to be a license" provision of the BPCI Act: questions and answers
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Drug Approval Licensure United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- This guidance is intended to provide answers to common questions about FDA's implementation of the "transition" provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262) on March 23, 2020 (the transition date). This guidance also describes FDA's compliance policy for the labeling of biological products that are the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the transition date and provide further clarity regarding the Agency's implementation of this statutory provision.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (24 pages)).
- NLM Unique ID:
- 101772627 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101772627