21 C.F.R. § 312.10

Waivers

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(a) A sponsor may request FDA to waive applicable requirement under this part. A waiver request may be submitted either in an IND or in an information amendment to an IND. In an emergency, a request may be made by telephone or other rapid communication means. A waiver request is required to contain at least one of the following:

(1) An explanation why the sponsor's compliance with the requirement is unnecessary or cannot be achieved;

(2) A description of an alternative submission or course of action that satisfies the purpose of the requirement; or

(3) Other information justifying a waiver.

(b) FDA may grant a waiver if it finds that the sponsor's noncompliance would not pose a significant and unreasonable risk to human subjects of the investigation and that one of the following is met:

(1) The sponsor's compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;

(2) The sponsor's proposed alternative satisfies the requirement; or

(3) The applicant's submission otherwise justifies a waiver.

[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9585, Mar. 4, 2002]

Notes of Decisions

Cited in 1 case, 1990–1990 · leading case: Anderson v. Dep't of Health & Human Servs., 907 F.2d 936 (10th Cir. 1990).

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Anderson v. Dep't of Health & Human Servs., 907 F.2d 936 (10th Cir. 1990). “21 C.F.R. § 312.10 . When adequate evidence of complete clinical testing has been submitted to the FDA, the sponsor may file an NDA, the approval of which is required before a drug can be marketed in interstate commerce.”

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