I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
In early March, the Massachusetts Attorney General's Office finalized the commonwealth's regulations on unfair and deceptive fees, which it refers to in its press release as "junk fee" regulations, while simultaneously...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more