U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
  1. Regulatory Information

GUIDANCE DOCUMENT

Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics May 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics

Docket Number:
2019-09529
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-09529 .