Zdrowie i gospodarka · 19.08.2011
Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Standards for Clinical Trial Imaging Endpoints." The purpose of this draft guidance is to assist sponsors in the use of imaging endpoints in clinical trials of therapeutic drugs and biological products. The draft guidance describes standards sponsors can use to ensure that clinical trial imaging data are obtained in a manner that complies with a trial's protocol, maintains imaging data quality, and provides a verifiable record of the imaging process.