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Postmarketing Safety: US FDA ‘Best Practices’ Include Weekly Adverse Event Screening For New Drugs

 
• By Sue Sutter

Agency’s approach to risk-based postmarketing safety surveillance explained in new draft document issued under the 21st Century Cures Act; product characteristics and intended use guide the frequency and extent of adverse event report screening, with newer drugs undergoing weekly reviews for three years after approval.

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US FDA takes a close look at adverse event reports every week for newly approved drugs. • Source: Shutterstock

The US Food and Drug Administration’s risk-based approach to postmarketing drug safety monitoring entails weekly screening of individual adverse event reports for three years after approval of certain drugs and biologics, the agency explains in a new draft document.

Products receiving weekly screening during their first three years on the market include: new molecular entities, novel biologics, biosimilars, and non-NMEs with new dosage forms or complex manufacturing processes.

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