Feb 12, 2019· Comment from Association for Accessible Medicines and the Biosimilars Council· FDA-2015-D-4750-0028
The Association for Accessible Medicines and the Biosimilars Council (collectively referred to as AAM) are pleased to provide comments to the Food and Drug Administration (FDA or the Agency) on its draft and final guidances for industry on implementation of the Deemed to be a License provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). AAM is submitting consolidated comments that address both FDAs draft guidance entitled The Deemed to be a License Provision of the BPCI Act: Questions and Answers (Draft Q&A Guidance) and FDAs final guidance on Interpretation of the Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009 (Final Guidance).