News from NORD

FDA Issues Guidance for More Efficient Approach to Drug Development for Rare Pediatric Diseases


 

The Food and Drug Administration (FDA) has released a draft guidance describing a possible new approach for companies to collaborate and test multiple drug products in the same clinical trials. Public comment is welcomed.

FDA also has issued a guidance on clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases.

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