Enclosed for FDA review are final reports on 2-year carcinogenicity studies with topically applied benzoyl peroxide gels in F344 rats and B6C3F1 mice submitted by the Benzoyl Peroxide Study Group of CHPA.
CHPA wishes to draw attention to varying restrictions on how nonprescription medicines can be displayed or accessed among European Union Member States as a barrier to market entry for such products.
This submission represents CHPA's detailed written comments as follow-up to the June meeting and is intended to complement the Association's oral presentation.
CHPA submits these comments on the proposal published by the Food and Drug Administration in 64 Fed. Reg. 66822 (November 30, 1999) to revise its citizen petition regulations, 21 C.F.R. § 10.25 and 21 C.F.R. § 10.30.
Request for agency exercise of enforcement discretion regarding the addition of new Warning language to Drug Facts labeling for Over-the-Counter benzocaine liquid/gel products indicated for relieving oral discomfort.
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