StacksVerified U.S. regulatory reference

21 CFR §316.28

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Each month FDA will update a publicly available cumulative posting of all drugs designated as orphan drugs. These postings will contain the following information:
  1. (a)The name and address of the sponsor;
  2. (b)The generic name and trade name, if any, or, if neither is available, the chemical name or a meaningful descriptive name of the drug;
  3. (c)The date of the granting of orphan-drug designation;
  4. (d)The designated use in the rare disease or condition; and
  5. (e)If the drug loses designation after August 12, 2013, the date of it no longer having designation.