21 C.F.R. § 600.90 Waivers.
Title 21 - Food and Drugs
(a) A licensed manufacturer may ask the Food and Drug Administration to waive under this section any requirement that applies to the licensed manufacturer 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: (1) An explanation why the licensed manufacturer's compliance with the requirement is unnecessary or cannot be achieved, (2) A description of an alternative submission that satisfies the purpose of the requirement, or (3) Other information justifying a waiver. (b) FDA may grant a waiver if it finds one of the following: (1) The licensed manufacturer's compliance with the requirement is unnecessary or cannot be achieved, (2) The licensed manufacturer's alternative submission satisfies the requirement, or (3) The licensed manufacturer's submission otherwise justifies a waiver.
Title 21: Food and Drugs
PART 600—BIOLOGICAL PRODUCTS: GENERAL
Subpart D—Reporting of Adverse Experiences
§ 600.90 Waivers.
