§ 312.10. Waivers.
194 words·~1 min read·
/us/cfr/t21/s§ 312.10·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
Connections12 cite this
Cited by 12 sections · top 11
Citation graph
cites case law
§ 312.10
Waivers.
Fed. Reg.×12
Cites 0Cited by 12 across 1 source