FDA Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI Act
Title:
FDA Guidance for Industry: Questions and Answers on
Biosimilar Development and
the BPCI Act
Origin/Publisher:
FDA
Content:
This 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).