Federal Register Notice: FDA is making available a guidance for industry entitled Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997. This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study status report for an approved human drug or licensed biological product; timeframes for FDA's review of postmarketing study commitments; and information about postmarketing study commitments that will be available to the public. To download this guidance, click here. To view this notice, click here.