U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Written Requests Issued
  1. Development Resources

Written Requests Issued

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act

NOTE: This list simply identifies approved active moieties to which FDA has issued a Written Request for pediatric studies since June 1998. If a product appears on this list, it does not imply that studies have been conducted or submitted to the Agency, nor does it mean that the studies described in the Written Request will be conducted. A sponsor is NOT required to perform pediatric studies in response to a Written Request. Conducting pediatric studies in response to a Written Request is voluntary. Upon occasion, information obtained by FDA subsequent to issuance of a Written Request causes FDA to rescind the Written Request. This list is not updated to indicate when a Written Request has been rescinded.

Back to Top