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FDA Proposes Streamlining Intercenter Agreements On Combo Products

This article was originally published in The Gray Sheet

Executive Summary

FDA is proposing to rescind an intercenter agreement between the Center for Biologics Evaluation & Research (CBER) and the Center for Drug Evaluation & Research (CDER) in order to modernize its oversight of combination products

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Regulatory News In Brief

Noncorrective contact lens crackdown: Nov. 24 FDA 1guidance clarifies that all contact lenses, including noncorrective lenses intended only to change the normal appearance or color of the eye, are subject to premarket authorization by FDA. Certain decorative lenses previously were regulated as cosmetics, but a November 2005 amendment to the Food, Drug & Cosmetic Act requires that all contact lenses be regulated as prescription devices and be dispensed only by licensed practitioners. Like all contact lenses, decorative lenses "can cause a variety of serious injuries or conditions" in the absence of supervision by a qualified eye care professional, the document states...

Regulatory News In Brief

Noncorrective contact lens crackdown: Nov. 24 FDA 1guidance clarifies that all contact lenses, including noncorrective lenses intended only to change the normal appearance or color of the eye, are subject to premarket authorization by FDA. Certain decorative lenses previously were regulated as cosmetics, but a November 2005 amendment to the Food, Drug & Cosmetic Act requires that all contact lenses be regulated as prescription devices and be dispensed only by licensed practitioners. Like all contact lenses, decorative lenses "can cause a variety of serious injuries or conditions" in the absence of supervision by a qualified eye care professional, the document states...

Combination Product Submissions Rose 10% In FY 2005 – FDA

FDA received 275 applications for combination products in fiscal year 2005, a 10% increase over the prior year, according to a May 29 report to Congress

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