clinical trials

Addressing the Tortoise in the Oncology Clinic

By Robert E. Winkler MD – COVID-19 vaccines were developed extremely fast, approximately nine months from pandemic emergence to FDA approval in the U.S. This is, by a landslide, a record for one of the fastest development (and approval) of a vaccine, and significantly faster than traditional R&D timelines.

A CDRH Priority: Clinical Trials in the US

By Owen Faris & Jeffrey Shuren – At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.