WASHINGTON, March 10 -- Food and Drug Administration has issued a notice called: New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on March 10 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry entitled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)." The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimi...