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§58.219. Reinstatement of a disqualified testing facility. — Inbound Citations

21 C.F.R. § 58.219

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 58.219 as a whole

  • (b) No nonclinical laboratory study begun by a testing facility after the date of the facility's disqualification shall be considered in support of any application for a research or marketing permit, unless the facility has been reinstated under § 58.219. The determination that a study may not be considered in support of an application for a research or marketing permit does not, however, relieve the applicant for such a permit of any obligation under any other applicable regulation to submit the results of the study to the Food and Drug Administration.