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 The revised draft guidance describes the procedures for requesting waivers, refunds, or reductions of these fees.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
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
