as of 2019 - 08 - 15

D.21 Guidance for Industry: Questions and Answers on Biosimilar Development and the BPCI ActThis guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA or the Agency).

D.21 Guidance for Industry:
Questions and Answers on Biosimilar Development and the BPCI Act1
Up4/2019
1

This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA or the Agency).

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