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21 U.S.C. § 360cc

Section 360cc - Protection for drugs for rare diseases or conditions
Section 360cc - Protection for drugs for rare diseases or conditions

2 Citing briefs

  1. Eagle Pharmaceuticals, Inc. v. Burwell et al

    MOTION for Summary Judgment [REDACTED]

    Filed March 29, 2017

    An entitlement to orphan drug exclusivity attaches automatically upon designation, contingent only upon approval of the drug and, according to FDA’s (unlawful) regulation, a showing of clinical superiority. See 21 U.S.C. § 360cc(a); 21 C.F.R. § 316.34(a).

  2. Ipsen Biopharmaceuticals, Inc. v. Price et al

    MOTION for Summary Judgment

    Filed May 8, 2017

    Case 1:16-cv-02372-ABJ Document 13 Filed 05/08/17 Page 12 of 36 6 treat patients with a rare disease, Somatuline ED earned orphan drug exclusivity under the FDCA. See 21 U.S.C. § 360cc; 21 C.F.R. § 316.31(a); Compl.