Zdrowie i gospodarka · 09/05/2003

Risk Management; Public Workshop; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening until May 30, 2003, the comment period for three concept papers entitled "Premarketing Risk Assessment," "Risk Management Programs," and "Risk Assessment of Observational Data: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment." The document that requested public input, review, and comments for the three concept papers was published in the Federal Register of March 7, 2003 (68 FR 11120). The agency is taking this action in response to informal requests for an extension of the comment period.