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...
FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applications to fit the FDA ri...
FDA publishes two final guidances on aspects of establishing bioequivalence.
Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exclude inappropriate t...
FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern oversight of medical ...
