[ Price : $8.95]
FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conj...[ Price : $8.95]
ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines.[ Price : $8.95]
FDA issues BPI Labs a Form-483 following an April inspection for potential cross-contamination risks at its outsourcing facility i...[ Price : $8.95]
Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment fo...[ Price : $8.95]
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the comme...[ Price : $8.95]
FDA and the drug industry conclude technical negotiations over the next iteration of the Prescription Drug User Fee Act, setting t...[ Price : $8.95]
An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in pharmaceutical advertising spen...[ Price : $8.95]
FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applicatio...