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News from the FDA

By ALM Staff | Law Journal Newsletters |
October 07, 2003

Notice of Public Workshops, Drug/Biological Products

A public workshop to discuss risk management activities for drug and biological products (excluding blood products other than plasma derivatives) has been announced. 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 pharmaco-vigilance. The input received at the workshop and from comments on the concept papers will be considered in drafting guidance for industry.

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