Current Regulations and Practices for Adverse Event Reporting: Implications for Labeling
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0092-8615/2000 Copyright 0 2000 Drug Information Association Inc.
CURRENT REGULATIONS AND PRACTICES FOR ADVERSE EVENT REPORTING: IMPLICATIONS FOR LABELING MICHAELR. HAMRELL, PHD President, MORIAH Consultants, Yorba Linda, California
Safety reporting and postmurketing 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, monitoc 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 b y the company regarding the product. The collection, review, reporting, and assessment of this safety experience information has a great impact on the labeling f o r 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. Key Words: Adverse experience; Safety; Labeling requirements
SAFETY REPORTING REQUIREMENTS POSTAPPROVAL MONITORING AND reporting is a regulatory requirement for marketing approval of a drug product. All applicants that have an approved new drug application (NDA), including an abbreviated new drug application, for a prescription drug for human use are required to report adverse experiences to the Food and Drug Administration (FDA). Section 21 CFR (1) requires the sponsor of an approved NDA to submit
Reprint address: Michael R. Hamrell, PhD. President, MORlAH Consultants, 4481 Paloma Lane, Yorba Linda, CA.
safety reports at various intervals to FDA. Each applicant is required to promptly review all adverse experience information obtained from any source. The applicant must report to the FDA all adverse experience information received at different intervals and timing depending on the nature and severity of the adverse experience. This includes all adverse drug experience information received by the applicant, from any source, foreign or domestic (2). Comparable requirements exist for the reporting of adverse experiences to the FDA for approved biologic products (3). Applicants of abbreviated applications are also expected to comply with the requirements for postmarketing reporting (4). These regulations were updated and re-
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Michael R. Hamrell
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vised recently to reflect changes in format and to be consistent with international expectations (5). An adverse drug experience is defined as any adverse event associated with the use of the drug in humans, whether or not
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