C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 316—ORPHAN DRUGS › Subpart C—Designation of an Orphan Drug

21 C.F.R. § 316.23

Timing of requests for orphan-drug designation; designation of already approved drugs

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(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.

(b) A sponsor may request orphan-drug designation of an already approved drug for an unapproved use without regard to whether the prior marketing approval was for a rare disease or condition.

[78 FR 35133, June 12, 2013]
Notes of Decisions
Cited in 5 cases (1 in the last 5 years), 2014–2026 · leading case: Pharm. Rsch. & Mfrs. of Am. v. United States Dep't of Health & Human Servs., 43 F. Supp. 3d 28 (D.D.C. 2014).
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Pharm. Rsch. & Mfrs. of Am. v. United States Dep't of Health & Human Servs., 43 F. Supp. 3d 28 (D.D.C. 2014). · cites it 2× “See 21 C.F.R. § 316.23 (a) ("A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.”
Eagle Pharm., Inc. v. Alex Azar, II, 952 F.3d 323 (D.C. Cir. 2020). “See 21 C.F.R. § 316.23 (a) (“A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.”
Pharm. Rsch. & Mfrs. of Am. v. United States Dep't of Health & Human Servs., 138 F. Supp. 3d 31 (D.C. Cir. 2015). · cites it 2× “See 21 C.F.R. § 316.23 (b). Nor does the designation of a drug as an orphan drug in and of itself afford a pharmaceutical manufacturer with the ability to market the drug in the United States.”
Pharm. Rsch. & Mfrs. of Am. v. United States Dep't of Health & Human Servs. (D.D.C. 2015). · cites it 2× “See 21 C.F.R. § 316.23 (b). Nor does the designation of a drug as an orphan drug in and of itself afford a pharmaceutical manufacturer with the ability to market the drug in the United States.”
Smart Approaches to Marijuana v. Kennedy (D.D.C. 2026). “See 21 C.F.R. § 316.23 . MMJ’s efforts have yet to see fruition.”
— 21 C.F.R. § 316.23(b) — 1 case
Pharm. Rsch. & Mfrs. of Am. v. United States Dep't of Health & Human Servs., 138 F. Supp. 3d 31 (D.C. Cir. 2015). “See 21 C.F.R. § 316.23 (b). Nor does the designation of a drug as an orphan drug in and of itself afford a pharmaceutical manufacturer with the ability to market the drug in the United States.”
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