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This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and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