FDA Technical Corrections Bill Could Address Trial Registry Requirements
This article was originally published in The Gray Sheet
Executive Summary
Clinical trial registry requirements contained in the recently enacted FDA Amendments Act are likely to be clarified in a "technical corrections" bill in the coming weeks, device industry lobbyists say
You may also be interested in...
House Adds Device Adverse Events To Trial Registry Requirements
Serious or frequent adverse events that occur during certain medical device clinical trials will need to be posted on a government Web site under a bill passed July 30 by the House
House Adds Device Adverse Events To Trial Registry Requirements
Serious or frequent adverse events that occur during certain medical device clinical trials will need to be posted on a government Web site under a bill passed July 30 by the House
CMS Maintains Status Quo On Clinical Trial Coverage, Again
Under intense pressure from Congress, industry and the medical research community, CMS has decided to maintain the status quo for coverage of routine costs in clinical trials