WASHINGTON, Oct. 13 -- Food and Drug Administration has issued a notice called: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Guidance for Industry; Availability.
The notice was published in the Federal Register on Oct. 13 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postap...