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§ 600.90 - Waivers.

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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.

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§ 600.82 - Notification of a permanent discontinuance or an interruption in manufacturing.
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