FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Plans Meeting on Real-World Evidence, Patient-Focused Drug Development

Aug. 15, 2019

The FDA has scheduled a Nov. 7 public meeting to discuss how to improve its drug development programs in the Office of New Drugs (OND) with the use of real-world evidence and an increase patient focus.

OND is “seeking suggestions on where we can provide regulatory clarity to promote innovative and effective drug development across multiple therapeutic areas,” the agency said.

The meeting will focus on specific policy suggestions the agency can adopt quickly to promote effective drug development. The agency will not invite specific presenters to the meeting; instead, stakeholders are encouraged to give their own presentations.

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