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
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key...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
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on the ORIENT-11 trial conducted exclusively in...more
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more