Law firms Hogan Lovells and Foley and Lardner advise pharmaceutical and medical device companies to maintain full inspection readiness while FDA under...
Former FDA commissioner Andrew C. von Eschenbach and former HHS secretary Tommy G. Thompson urge policymakers to prioritize leadership and institution...
A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical devices to market coul...
FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies.
ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines.
FDA issues BPI Labs a Form-483 following an April inspection for potential cross-contamination risks at its outsourcing facility in Largo, FL.
Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma ...
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the commercial market after b...
