Zdrowie i gospodarka · 05/08/2014

FDA Releases Draft Guidance on Reference Product Exclusivity for Biological Products

The Food and Drug Administration (FDA) has made available a draft guidance document to help industry sponsors and other stakeholders determine the date of first licensure for a reference product under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which aims to create an abbreviated licensure pathway for biosimilar biological products.