Healthy Skepticism Library item: 9598

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Revision of rules governing postmarketing reporting of adverse drug reactions
Federal Register 1987 Oct 13; 52:37931-37936

Abstract:

The Food and Drug Administrations revision of the regulations governing the postmarketing reporting of adverse drug reactions associated with the use of approved new drugs and prescription drugs without approved new drug applications is presented. Requirements for the submission of serious and unexpected drug reactions reports to the FDA no later than 15 days after the marketer learns of the reaction (15-day Alert reports) and the reporting obligations of the drug firm conducting postmarketing studies have been modified. The changes are intended to improve the effectiveness of the FDA’s postmarketing surveillance of drugs by focusing the review on truly serious adverse reactions. These final regulations are effective November 12, 1987.