21 CFR 201.58 - Waiver of labeling requirements.
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An applicant may ask the Food and Drug Administration to waive any requirement under §§ 201.56, 201.57, and 201.80. A waiver request must be submitted in writing to the Director (or the Director's designee), Center for Drug Evaluation and Research, Food and Drug Administration, Central Document Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, or, if applicable, the Director (or the Director's designee), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200 North, Rockville, MD 20852-1448. The waiver must be granted or denied in writing by the Director or the Director's designee.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.