FDA Issues Final Guidance on Risk Management of Drugs and Biologics

"The U.S. Food and Drug Administration (FDA) recently issued three final guidances based on draft guidances published in May 2004. The final guidances are directed at improving the assessment and monitoring of risks associated with drugs and biological products in clinical development and general use.

The first of the final guidances relates to premarket risk assessment and focuses on considerations for the stages of clinical development of products. It builds on a number of existing FDA and ICH guidances related to preapproval safety assessments.

The second guidance deals with the development and use of risk minimization action plans. It includes a call for broader input from patients, health care professionals and the public when recommendations are made on whether to initiate, revise or end risk minimization interventions.

The third final guidance, addressing heightened postmarketing vigilance, recommends reporting and analytical practices for monitoring the safety concerns and risk of medical products in general use."

For more information, please see this Pharmacapsules @ Gowlings report.