JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions published in 2016 and...more
The Food and Drug Administration (FDA) recently announced that it had identified “significant data integrity and study conduct concerns” with bioequivalence studies conducted by the India-based contract research organization...more
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more