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FDA issues guidance on drug safety plans

The US Food and Drug Administration has published guidance for drug safety plans to be used and followed by pharmaceutical companies
The US Food and Drug Administration (FDA) has published guidance for drug safety plans to be used and followed by pharmaceutical companies.

The FDA has identified 25 drugs and biologic products that will require submission of a formal Risk Evaluation and Mitigation Strategy (REMS), an official safety plan.

Certain medicines can present problems in terms of side effects when used by certain groups (pregnant women, for example) but remain efficacious when employed for their indicated purpose.

Through the new law, the FDA has specific enforcement authority to deal with companies or individuals that violate or fail to comply with the REMS requirements.

Jane Axelrad, associate director for policy for the FDA's Center for Drug Evaluation and Research, said: ìThese safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use.

"The FDA approved drugs identified today before the new law was passed and they will now be brought under the new statutory authority to require and enforce REMS."

28th March 2008

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