RWD & RWE in FDA submissions

New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics

This guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of a regulatory submission to FDA to provide information on their use of RWE in a simple, uniform format. FDA will use this information for internal tracking purposes only. This guidance applies to submissions for investigational new drug applications (INDs), new drug applications (NDAs), and biologics license application (BLAs) that contain RWE used to support regulatory decisions regarding safety and/or effectiveness.

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