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 guidance providing recommendations regarding waivers, refunds, and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, & Cosmetic Act (FD&C Act). The final guidance revises the September 2011 document, User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.
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: FDA
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
