New and Revised Draft Q & As on Biosimilar Development and the BPCI Act (Revision 3)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2). ” The question and answer (Q&A) format is intended to inform prospective applicants and facili
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news