U.S. FDA Deadline on”Deemed to be a License” Biologics Approvals

Draft Guidance BiologicsThe US Food and Drug Administration (FDA) will not approve any pending or tentatively approved application for a biological product under the Federal Food, Drug, and Cosmetic (FD&C) Act after 23 March 2020. According to authors of an article featured in the most recent RAPS eNewsletter, FDA draft guidance on the “deemed to be a license” provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2009 is now available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf

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