The U.S. Food and Drug Administration (FDA) has issued a draft guidance on “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings” encouraging industry to include patients with […]
A new report from an independent research group gives the U.S. Food and Drug Administration (FDA) generally good marks for how the agency currently uses patient experience data to […]
A new guidance from the U.S. Food and Drug Administration (FDA) provides recommendations and updated information to help sponsors comply with the expedited safety reporting requirements for human drug […]
The COVID-19 pandemic “exposed severe disparities in our healthcare system,” including the relative lack of diversity in the clinical trial patient population, Bashar Shihabuddin, MD, MS, a professor of emergency medicine […]
A study involving virtual rather than real patients was as effective as traditional clinical trials in evaluating a medical device used to treat brain aneurysms, according to new research. […]