HHS-OIG HHS OIG Reviews FDA’s Accelerated Approval of Aducanumab Thomas Sullivan Mar 12, 2025 0 Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) conducted a…
FDA REMS: FDA’s Application of Statutory Factors in Determining When a REMS Is… Thomas Sullivan Apr 22, 2019 0 Recently the FDA issued final guidance on FDA’s application of the statutory factors in determining when a risk evaluation and…
Congress Letters from Grassley: Are Statins Safe? Is the Sky Blue? Thomas Sullivan Sep 28, 2009 0 Simple questions deserve simple answers. So when Senator Grassley (R-IA) recently sent a letter to the Food and…
