§600.90. Waivers.
21 C.F.R. § 600.90
An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:
An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved,
A description of an alternative submission that satisfies the purpose of the requirement, or
Other information justifying a waiver.
FDA may grant a waiver if it finds one of the following:
The applicant's compliance with the requirement is unnecessary or cannot be achieved,
The applicant's alternative submission satisfies the requirement, or
The applicant's submission otherwise justifies a waiver.
Notes, amendments, and revision history
Amendments
[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]
Source
Source: 59 FR 54042, Oct. 27, 1994, unless otherwise noted.
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 356c, 356e, 360, 360i, 371, 374, 379k-l; 42 U.S.C. 216, 262, 263, 263a, 264.
Amendments
[59 FR 54042, Oct. 27, 1994, as amended at 79 FR 33092, June 10, 2014]