Zdrowie i gospodarka · 05/05/2004

FDA Releases Draft Guidances for Industry on Risk Assessment and Pharmacovigilance Practices

The Food and Drug Administration (FDA) has made available three draft guidances for industry on premarketing risk assessment, risk minimization action plans, and good pharmacovigilance practices, all dated May 2004, to provide guidance on managing risks associated with drug products in the CDER and CBER.