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
INTERPHEX 2025: Use of Walk-In Chambers for Bio/Pharma Development and Manufacturing
April 2nd 2025Sitting down with the PharmTech Group at INTERPHEX 2025, Christopher Murphy, director of Global Business Development and Service Customer Support at Environmental Specialties, discusses the design and critical role of walk-in chambers in the bio/pharmaceutical industry.
