Guidance for Industry on Submission of Abbreviated Reports and Synopses in Support of Marketing Applications; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submission of Abbreviated Reports and Synopses in Support of Marketing Applications.'' This guidance, which implements section 118 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act), is intended to assist applicants who wish to submit abbreviated reports and synopses in lieu of full reports for certain clinical studies, both in marketing applications for new products and in supplements to approved applications. The guidance describes which studies may be submitted as abbreviated reports or synopses and describes a format for such submissions.