In a Law360 article, health care partner David Peloquin discussed recent U.S. Food and Drug Administration guidance on how sponsors of new medical products can conduct decentralized clinical trials. Rather than requiring study participants to visit a central location, the guidance explains how a trial can include telehealth visits, in-home monitoring and appointments at local health clinics.
David notes the FDA guidance could prove useful to boosting the diversity of communities participating in medical research. With clearer rules for remote participation, David said, researchers can look beyond the communities close enough to travel to a research institution and meet trial participants where they are.
Attorneys
Stay Up To Date with Ropes & Gray
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
Stay in the loop with all things Ropes & Gray, and find out more about our people, culture, initiatives and everything that’s happening.
We regularly notify our clients and contacts of significant legal developments, news, webinars and teleconferences that affect their industries.