21 C.F.R. § 316.26 Amendment to orphan-drug designation.
Title 21 - Food and Drugs
(a) At any time prior to approval of a marketing application for a designated orphan drug, the sponsor holding designation may apply for an amendment to the indication stated in the orphan-drug designation if the proposed change is due to new and unexpected findings in research on the drugs, information arising from FDA recommendations, or unforeseen developments in treatment or diagnosis of the disease or condition. (b) FDA will grant the amendment if it finds that the initial designation request was made in good faith and that the amendment is intended to conform the orphan-drug designation indication to the results of unanticipated research findings, to unforeseen developments in the treatment or diagnosis of the disease or condition, or to changes based on FDA recommendations, and that, as of the date of the submission of the amendment request, the amendment would not result in exceeding the prevalence or cost recovery thresholds in §316.21 (a)(1) or (a)(2) upon which the drug was originally designated.
Title 21: Food and Drugs
PART 316—ORPHAN DRUGS
Subpart C—Designation of an Orphan Drug
§ 316.26 Amendment to orphan-drug designation.
