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

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

FDA

Inhalt:
This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation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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