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
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
