FDA's interpretation of the Biologics Price Competition and Innovation Act's "transition provisions" for certain protein products would create a "dead zone" or "blackout" period for new applications that could last several years, industry stakeholders say.
In comments responding to an FDA draft guidance on the BPCIA's "deemed to be a license" provisions, representatives from innovator, generic and biosimilar industries say the agency should allow pending NDAs and ANDAs for affected products to be reviewed and approved after March 23, 2020
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