The Food and Drug Administration’s Center for Drug Research is asking for comments on its draft guidance for the adverse reaction section of labels for prescription drugs and biologics. The idea is to make the information “clear, easy to find and consistent” on labels, thus warning of possible adverse reactions to drugs or a combination of drugs. The FDA is proposing that manufacturers highlight adverse reactions that require medical attention. It suggests that this section be limited to information that can be helpful in treating, monitoring and advising patients, thus avoiding long and exhaustive lists of infrequent or minor adverse reactions. An FDA spokesperson said this guidance is part of an overall effort to ensure that labels and package inserts are “as clear as possible and as accessible as possible.” Comments are due by September 18, 2000.
Drug labeling eyed
The FDA is proposing that manufacturers highlight adverse reactions that require medical attention on labels.
Jul 31st, 2000