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
PacBio Chosen as Tech Partner for Global Alzheimer’s Disease Research Project
April 23rd 2025The project, the North African Dementia Registry, will unite multiple entities for the purpose of developing a comprehensive dataset to advance the research community’s understanding of Alzheimer’s disease and other dementias in diverse populations.
