21 Food and Drugs 4 2003-04-01 2003-04-01 false Requests for waiver of requirement for adequate and well-controlled studies to substantiate certain labeling statements. 201.58 Section 201.58 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin
§ 201.58 Requests for waiver of requirement for adequate and well-controlled studies to substantiate certain labeling statements.

A request under § 201.57(b)(2)(ii), (c)(2), (c)(3)(i), (c)(3)(v), (f)(9), and (g)(4) for a waiver of the requirements of § 314.126(b) of this chapter shall be submitted in writing as provided in § 314.126(b) to the Director, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20587, or, if applicable, the Director, Center for Biologics Evaluation and Research, 8800 Rockville Pike, Bethesda, MD 20892. The waiver shall be granted or denied in writing by such Director or the Director's designee.

[55 FR 11576, Mar. 29, 1990]