Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability

概要

The Food and Drug Administration (FDA) is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the Federal Register on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's first report on the status of the study commitments that sponsors have agreed to conduct and for which an annual status report on the study has been received by FDA.