The proposed FDA guidance would let sponsors add patient-specific gene editing variants to approved BLAs via in vitro data, with comments due November 27, 2026.
|Articles|October 21, 2019
FDA Publishes Guidance on User Fees
Author(s)BioPharm International Editors
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
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On October 16, 2019, FDA announced the publication of
The guidance describes how to request waivers, refunds, and reductions that are available under the FD&C Act as well as the process for requesting an appeal of an FDA decision. The guidance also clarifies related issues such as exceptions for orphan drugs.
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