C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses

21 C.F.R. § 314.500

Scope

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This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).

[57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999]
Notes of Decisions
Cited in 8 cases (3 in the last 5 years), 2008–2023 · leading case: All. Hippocratic Med. v. FDA, 78 F.4th 210 (5th Cir. 2023).
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All. Hippocratic Med. v. FDA, 78 F.4th 210 (5th Cir. 2023). · cites it 4× “” 21 C.F.R. § 314.500 . And pregnancy is plainly not an illness.”
Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347 (Fed. Cir. 2018). “Because of its potential for abuse, the FDA approved Xyrem ® under "restricted distribution regulations contained in [ 21 C.F.R. § 314.500 ] (Subpart H) to assure safe use of the product.”
New Jersey Carpenters Pension & Annuity Funds v. Biogen Idec Inc., 537 F.3d 35 (1st Cir. 2008). “4 See 21 C.F.R. §§ 314.500 , 314.510. *40 In August 2000, Biogen and another company, Elan Pharma International Limited (“Elan”), announced that they had entered into a joint collaboration agreement to bring TYSABRI to market.”
Tummino v. Hamburg, 936 F. Supp. 2d 162 (E.D.N.Y 2013). “” 21 C.F.R. § 314.500 . The FDA amended 21 C.”
Shareholder Rep. Servs. LLC v. Shire US Holdings, Inc. (Del. Ch. 2020). · cites it 2× “” JX-1698 ¶ 62 (citing 21 C.F.R. § 314.500 ); see 21 C.F.R. § 314.”
All. Hippocratic Med. v. FDA (5th Cir. 2023). · cites it 2× “” 21 C.F.R. § 314.500 . Originally, Subpart H was intended to promote rapid approval for life-saving HIV-AIDS drugs.”
Seife v. Food & Drug Admin. (S.D.N.Y. 2020). “21 C.F.R. 314.500; see 21 U.S.C. § 356 (c)(1)(A).”
GenBioPro, Inc. v. Raynes (S.D.W. Va 2023). “” 21 C.F.R. §§ 314.500 , 314.520; Compl. ¶ 36.”
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