Public Workshop on Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products-Looking Forward; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing a public workshop titled "Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products--Looking Forward." The purpose of the public workshop is to provide interested parties with an update on FDA's current activities related to real- world evidence (RWE) and to share accomplishments, ongoing challenges, and future opportunities. The public workshop will discuss potential next steps to promote the continued evolution and consistent application of real-world data (RWD) in drug development. This public workshop will be convened and supported by a cooperative agreement between FDA and the Duke University, Duke-Margolis Institute for Health Policy.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.