Safety Reporting Requirements for Human Drug and Biological Products; Extension of Comment Period

Streszczenie

The Food and Drug Administration (FDA) is extending to October 14, 2003, the comment period for a proposed rule published in the Federal Register of March 14, 2003 (68 FR 12406). The proposed rule would amend the agency's pre- and postmarketing safety reporting regulations for human drug and biological products. The agency is taking this action in response to a request for more time to submit comments to FDA.