21 CFR 316.29 - Revocation of orphan-drug designation.

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There is 1 rule appearing in the Federal Register for 21 CFR 316. View below or at eCFR (GPOAccess)
§ 316.29 Revocation of orphan-drug designation.
(a) FDA may revoke orphan-drug designation for any drug if the agency finds that:
(1) The request for designation contained an untrue statement of material fact; or
(2) The request for designation omitted material information required by this part; or
(3) FDA subsequently finds that the drug in fact had not been eligible for orphan-drug designation at the time of submission of the request therefor.
(b) For an approved drug, revocation of orphan-drug designation also suspends or withdraws the sponsor's exclusive marketing rights for the drug but not the approval of the drug's marketing application.
(c) Where a drug has been designated as an orphan drug because the prevalence of a disease or condition (or, in the case of vaccines, diagnostic drugs, or preventive drugs, the target population) is under 200,000 in the United States at the time of designation, its designation will not be revoked on the ground that the prevalence of the disease or condition (or the target population) becomes more than 200,000 persons.
(d) If FDA revokes orphan-drug designation, FDA will publicize that the drug is no longer designated in accordance with § 316.28(e).
[57 FR 62085, Dec. 29, 1992, as amended at 78 FR 35134, June 12, 2013]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-12-23; vol. 79 # 246 - Tuesday, December 23, 2014
    1. 79 FR 76888 - Policy on Orphan-Drug Exclusivity; Clarification
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; clarification on policy.
      Effective December 23, 2014.
      21 CFR Part 316

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 316 after this date.

  • 2014-12-23; vol. 79 # 246 - Tuesday, December 23, 2014
    1. 79 FR 76888 - Policy on Orphan-Drug Exclusivity; Clarification
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; clarification on policy.
      Effective December 23, 2014.
      21 CFR Part 316