FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: BIOSIMILAR USER FEE ACT III FUTURE NEEDS IN THE DEVELOPMENT OF INTERCHANGEABLE PRODUCTS POST-WORKSHOP; DRAFT STRATEGY DOCUMENT

WASHINGTON, Sept. 18 -- Food and Drug Administration has issued a notice called: Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document.

The notice was published in the Federal Register on Sept. 18 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, "Advancing the Development...