FDA Publishes User Fee Guidance
The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.
On June 20, 2018, FDA released guidance providing recommendations for requests for waivers, refunds, and reductions of user fees for drugs and biologics. The new guidance revises the 2011 guidance User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.
These user fees are assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revised draft guidance describes the procedures for requesting waivers, refunds, or reductions of these fees. It also describes the process to follow if FDA denies a company’s request. Clarification on related issues such as user fee exemptions for orphan drugs is also provided.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
