FDA Guidance for Industry: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

Titel:
FDA Guidance for Industry: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
Internet:

https://www.gmp-navigator.com/files/guidemgr/34719565dft.pdf

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This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and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