FDA to Convert Some NDAs to BLAs on March 23, 2020
This Bulletin is brought to you by AHLA’s Life Sciences Practice Group.
- February 13, 2020
- Lindsay P. Holmes , BakerHostetler
- Lee H. Rosebush , BakerHostetler
- Marc Wagner , BakerHostetler
As the March 23, 2020 transition date quickly approaches for the "Deemed to be a License" (Deemed BLA) provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), more stakeholders have become interested in the implications to their health care businesses. This transition will convert New Drug Applications (NDAs) to Biologic License Applications (BLAs) and remove the NDAs from FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the "Orange Book").
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