DEVICES EXCLUDED FROM FDA CLINICAL TRIALS DATABASE FOR AT LEAST TWO YEARS UNDER SENATE FDA REFORM BILL; HOUSE REFORM MEASURE SLATED FOR VOTE OCT. 6 OR 7
This article was originally published in The Gray Sheet
Executive Summary
Device manufacturers get a reprieve of at least two years on inclusion of clinical trial data in a public FDA database under the "FDA Modernization and Accountability Act of 1997" (S 830) approved by the Senate Sept. 24 ("The Gray Sheet" Sept. 29, p. 3).
You may also be interested in...
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.
Biogen Sees Improving Momentum In Slow Leqembi Launch
Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.
Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease
Vivalink will provide ECG wearable technology to monitor patients in RSRT’s Vibrant study, which is aimed at assessing autonomic dysfunction in children with Rett syndrome.