21 CFR 320.63 - Retention of bioequivalence samples.

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§ 320.63 Retention of bioequivalence samples.

The applicant of an abbreviated application or a supplemental application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or, if bioequivalence testing was performed under contract, the contract research organization shall retain reserve samples of any test article and reference standard used in conducting an in vivo or in vitro bioequivalence study required for approval of the abbreviated application or supplemental application. The applicant or contract research organization shall retain the reserve samples in accordance with, and for the period specified in, § 320.38 and shall release the reserve samples to FDA upon request in accordance with § 320.38.

[ 58 FR 25928, Apr. 28, 1993, as amended at 64 FR 402, Jan. 5, 1999]

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United States Code

Title 21 published on 09-Jun-2018 03:51

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 320 after this date.

  • 2016-10-06; vol. 81 # 194 - Thursday, October 6, 2016
    1. 81 FR 69580 - Abbreviated New Drug Applications and 505(b)(2) Applications
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 5, 2016.
      21 CFR Parts 314 and 320