C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart C—Administrative Actions

21 C.F.R. § 312.41

Comment and advice on an IND

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(a) FDA may at any time during the course of the investigation communicate with the sponsor orally or in writing about deficiencies in the IND or about FDA's need for more data or information.

(b) On the sponsor's request, FDA will provide advice on specific matters relating to an IND. Examples of such advice may include advice on the adequacy of technical data to support an investigational plan, on the design of a clinical trial, and on whether proposed investigations are likely to produce the data and information that is needed to meet requirements for a marketing application.

(c) Unless the communication is accompanied by a clinical hold order under § 312.42, FDA communications with a sponsor under this section are solely advisory and do not require any modification in the planned or ongoing clinical investigations or response to the agency.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]
Notes of Decisions
Cited in 1 case, 2010–2010 · leading case: Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010).
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Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010). “See 21 C.F.R. § 312.41 (a). Throughout, the FDA “monitor[s] the progress of the conduct and evaluation of clinical trials” and is “involved in facilitating their appropriate progress.”
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