FDA says an Abbott recall of some Endurity and Assurity bradycardia pacemakers is Class 1.
University of Connecticut pharmacy professor C. Michael White says FDA may be too dependent on user fees and needs more taxpayer funding for programs ...
FDA accepts for review a Strongbridge Biopharma NDA for Recorlev (levoketoconazole) for treating endogenous Cushing's syndrome.
Federal Register notice: FDA makes available a final guidance entitled M9 Biopharmaceutics Classification System-Based Biowaivers.
The CDER Office of Surveillance and Epidemiology issues its first annual report dealing with four core functions and looking to the future.
CDRH director Jeff Shuren tells an industry conference that FDA will likely favor a hybrid inspection program going forward in the post-Covid-19 world...
Federal Register notice: FDA makes available a final guidance entitled E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sens...
The Justice Department says a federal grand jury indicted a Miami clinical trial coordinator for conspiring to falsify clinical trial data and making ...