“FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the
safety of trial participants, maintaining compliance with good clinical practice (GCP), and
minimizing risks to trial integrity during the COVID-19 pandemic.”
FDA has issued a final guidance on Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”. The document, issued on June 16th, can be accessed through the following link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm348890.pdf There will also be a webinar on the final guidance on July 21, 2016. It will take place […]
Dr. Gad frequently teaches courses, through the Center for Professional Advancement (CfPA), on various broad-based topics in toxicology. Listed below are his upcoming courses, all of which are open for registration! To take advantage of our 10% Course Director Referral Discount, when you register simply use the code CD508. We look forward to seeing you! Non-Clinical Drug Safety […]