FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies.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.
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 ...
FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that could cause serious ...
