Orphan Drug Designation
Orphan Drug Designation. Means a grant by the Food and Drug Administration of the United States of a request for designation as an orphan drug under Section 526 of the Federal Food, Drug and Cosmetics Act as amended by Section 2 of the Orphan Drug Act (sections 525-528 (21 U.S.C. §360aa-dd)), and its related regulations (including 21 C.F.R. §316 et seq.).
Found in
Upstream Bio, Inc. contract
Orphan Drug Designation. Means designation by FDA of a product as an orphan drug in accordance with the provisions of 21 C.F.R. § 316.20.
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