ICMAD Testifies at FDA Hearings

Mar 28, 2014 | Contact Author | By: Cosmetics & Toiletries editors
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Title: ICMAD Testifies at FDA Hearings
ICMADx OTC drugsx drug applicationsx
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Keywords: ICMAD | OTC drugs | drug applications

Abstract: Independent Cosmetic Manufacturers and Distrubutors (ICMAD) board member Craig Weiss, president of Consumer Product Testing, testified on March 25, 2014, during recent U.S. Food and Drug Administration (FDA) hearings on modernizing over-the-counter drugs.

Independent Cosmetic Manufacturers and Distrubutors (ICMAD) board member Craig Weiss, president of Consumer Product Testing, testified on March 25, 2014, during recent U.S. Food and Drug Administration (FDA) hearings on modernizing over-the-counter drugs. On behalf of ICMAD, Weiss commended the FDA on its initiative to modernize and streamline the Monograph proceedings, although he noted the importance of completing and finalizing open Monographs.

He strongly urged the Agency to provide clear guidance on the required safety and efficacy of data needed to facilitate ingredient approvals for new OTC drugs, as well as maintain the approval of new ingredients by therapeutic class rather than adopting the review required for new drug applications. He further urged the Agency to revisit the pending time and extent applications, and establish procedures to move these along more efficiently, stressing the importance of these products to consumers.