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
Everyone is likely aware that the FDA is one of the agencies tasked with the job of overseeing and ensuring the safety of the nation’s food supply. Have you considered how the cost of the food safety regulatory work of the...more
Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more
In a notice of proposed rulemaking issued on October 11, 2017 (the “NPRM”), the U.S. Department of the Treasury (“Treasury”) and the Internal Revenue Service (“IRS”) proposed an amendment to existing regulations (the...more
The exuberance of a November election victory for Republicans has given way to the difficult reality of passing legislation in a closely divided Senate. While the GOP has made significant gains in the area of regulatory...more