FDA DRAFT GUIDANCE ON THE ACCEPTANCE OF FOREIGN CLINICAL DATA ON DEVICES

FDA DRAFT GUIDANCE ON THE ACCEPTANCE OF FOREIGN CLINICAL DATA ON DEVICES ; PRODUCT INFO Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download. PURCHASE VIDEO As medical device innovation continues to expand rapidly, regulators...

MEDDEV 2.7.1 REV 4: IMPLEMENTING NEW REQUIREMENTS FOR CLINICAL EVALUATION REPORTS (CER)

MEDDEV 2.7.1 REV 4: IMPLEMENTING NEW REQUIREMENTS FOR CLINICAL EVALUATION REPORTS (CER) ; PRODUCT INFO Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download. PURCHASE VIDEO In an effort to increase the safety and reliability of...

CMIOs Report Frequent Clinical Decision Support Tool Malfunctions, Survey Finds

“A survey of chief medical information officers (CMIOs) found that 93 percent of CMIOs reported experiencing at least one clinical decision support systems malfunction and 38 percent reported four or more malfunctions a year, according to a study published in...

ICYMI: US FDA Explains Criteria for Accepting Medical Device Clinical Data from Foreign Studies

“New draft guidance from the US Food and Drug Administration proposes Good Clinical Practice (GCP) compliance for accepting medical device clinical data from studies conducted in foreign countries, and also outlines criteria the agency uses for accepting such...

ICYMI: WHO Joins the Push for Greater Disclosure of Clinical Trial Data

In an article from the Wall Street Journal, “In the latest push to expand access to clinical trial data, the World Health Organization has released a new position statement calling for companies to publish all research studies and suggested specific timetables...