21 C.F.R. § 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
Title 21 - Food and Drugs
(a) Any person planning to conduct an in vivo bioavailability or bioequivalence study in humans shall submit an “Investigational New Drug Application” (IND) if: (1) The test product contains a new chemical entity as defined in §314.108(a) of this chapter; or (2) The study involves a radioactively labeled drug product; or (3) The study involves a cytotoxic drug product. (b) Any person planning to conduct a bioavailability or bioequivalence study in humans using a drug product that contains an already approved, non-new chemical entity shall submit an IND if the study is one of the following: (1) A single-dose study in normal subjects or patients where either the maximum single or total daily dose exceeds that specified in the labeling of the drug product that is the subject of an approved new drug application or abbreviated new drug application. (2) A multiple-dose study in normal subjects or patients where either the single or total daily dose exceeds that specified in the labeling of the drug product that is the subject of an approved new drug application or abbreviated new drug application. (3) A multiple-dose study on an extended release product on which no single-dose study has been completed. (c) The provisions of parts 50, 56, and 312 of this chapter are applicable to any bioavailability or bioequivalence study in humans conducted under an IND. (d) A bioavailability or bioequivalence study in humans other than one described in paragraphs (a) through (c) of this section is exempt from the requirements of part 312 of this chapter if the following conditions are satisfied: (1) If the study is one described under §320.38(b) or §320.63, the person conducting the study, including any contract research organization, shall retain reserve samples of any test article and reference standard used in the study and release the reserve samples to FDA upon request, in accordance with, and for the period specified in, §320.38; and (2) An in vivo bioavailability or bioequivalence study in humans shall be conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, and informed consent set forth in part 50 of this chapter. [57 FR 18000, Apr. 28, 1992, as amended at 58 FR 25927, Apr. 28, 1993; 67 FR 77674, Dec. 19, 2002]
Title 21: Food and Drugs
PART 320—BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Subpart B—Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
§ 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
