
FDA Publishes Guidance on User Fees
The guidance discuses waivers, refunds, and reductions of user fees under sections 735 and 736 of the FD&C Act.
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.
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.