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 ...
The 2nd Circuit Court of Appeals upholds a New York federal courts dismissal of a suit claiming that Pfizer failed to properly warn that its Lipitor c...
Federal Register notice: FDA makes available a final guidance entitled S11 Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceu...