Current Regulations and Practices for Adverse Event Reporting: Implications for Labeling

Abstract

Safety reporting and postmarketing surveillance is one of the most important responsibilities of a manufacturer following approval of a new drug. New drug products are approved and placed on the market in the United States under the Federal Food Drug and Cosmetic (FD&C) Act. The FD&C Act allows for the approval of drugs that are safe and effective as determined by appropriate experts, qualified by training and experience to make such determinations. Following approval, the sponsor of each drug product is required to collect, monitor, and report to the Food and Drug Administration on all significant new developments with the drug product, including but not limited to, adverse drug experiences received by the company regarding the product. The collection, review, reporting, and assessment of this safety experience information has a great impact on the labeling for a product and the information provided to practitioners on a continuing basis regarding the safe use of a product. Thus, new safety information and the company’s reaction to this information is very important in providing accurate and up-to-date information to medical practitioners.