[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.58]
[Page 38]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart B Labeling Requirements for Prescription Drugs and/or Insulin
Sec. 201.58 Waiver of labeling requirements.
An applicant may ask the Food and Drug Administration to waive any
requirement under Sec. Sec. 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, 5600 Fishers Lane, Rockville, MD 20857, 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.
[71 FR 3996, Jan. 24, 2006]
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