FDA PROPOSED RULE: SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS, AN IMPLEMENTATION PLAN FOR POSTMARKETING SAFETY REPORTING AT MEDIMMUNE.

Abstract

In March 2003, the United States Food and Drug Administration (FDA) issued a proposed rule titled, "Safety Reporting Requirements for Human Drug and Biological Products." This rule, upon codification, will have a significant impact on safety reporting processes in the pharmaceutical and biotechnology industries. The proposed changes will require Pharmacovigilance departments in industry to revise procedures relating to FDA safety reporting. An implementation plan is therefore an essential tool to ease the transition from complying with current regulations to complying with the regulations outlined in the proposed rule. The proposed rule encompasses changes to almost all aspects of safety reporting. This implementation plan for the Pharmacovigilance department at MedImmune will focus on three areas; terminology and definitions, followup reports, and medication errors. This plan will play a key role in ensuring that MedImmune is moving towards compliance with the proposed rule and will make the transition less burdensome.