Expedited Safety Reporting Requirements for Human Drug and Biological Products

The Food and Drug Administration (FDA) is amending its expedited safety reporting regulations for human drug and biological products to provide consistency with the elements of FDA Form 3500A for use in pre- and postmarketing safety reporting; implement definitions, reporting periods, formats, and standards as recommended by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and by the World Health Organization's Council for International Organizations of Medical Sciences (CIOMS); require applicants, manufacturers, packers, and distributors, as well as licensed manufacturers and other manufacturers of biological products, to develop written procedures for postmarketing safety monitoring and reporting; state that FDA Form 3500A reports that FDA forwards to any person subject to the postmarketing safety reporting requirements are not required to be resubmitted to the agency; and make other revisions to the regulations to provide uniformity with definitions and procedures used in expedited pre- and postmarketing safety reporting for human drug and biological products. These changes simplify and facilitate expedited safety reporting and enhance agencywide consistency in the collection of postmarketing safety data.