201.58—Waiver of labeling requirements.

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.

Code of Federal Regulations

[71 FR 3996, Jan. 24, 2006, as amended at 74 FR 13112, Mar. 26, 2009]

CFR

201.58—Waiver of labeling requirements.

Code of Federal Regulations