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CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence

 
• By Sue Sutter

US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

To do list
FDA's drugs center is out with its annual guidance "to do" list. • Source: Shutterstock

The US Food and Drug Administration’s Center for Drug Evaluation and Research aims to release new guidance in 2021 explaining how sponsors can demonstrate substantial evidence of effectiveness with a single adequate and well-controlled study.

CDER’s guidance

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