FDA Guidance for Industry: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)

Title:
FDA Guidance for Industry: New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)

https://www.gmp-compliance.org/files/guidemgr/UCM273001.pdf

Origin/Publisher:

FDA

Content:
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

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