Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009
🏛 Food and Drug Administration (FDA)FDA-2015-D-4750
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Rules, notices, and supporting material — the primary rule pinned first.
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OtherMar 5, 2020
The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for IndustryNo comment period💬 4,223 comments · 1,380 awaiting analysis