Zdrowie i gospodarka · 7.03.2003

Risk Management; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop to discuss risk management activities for drug and biological products (excluding blood products other than plasma derivatives). The purpose of the workshop is to present FDA's current thoughts on risk management activities and to solicit views from the public. To facilitate public input and discussion, FDA is issuing for review and comment three concept papers that focus on risk assessment, risk management, and pharmacovigilance. The input received at the workshop and from comments on the concept papers will be considered in drafting guidance for industry.