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FDA-USP workshop to preview updated OTC standards
Date:8/15/2011

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In addition to Dr. Woodcock, day one of the workshop will feature opening remarks from Scott Melville, chief executive officer of CHPA and Roger Williams, M.D., chief executive officer of USP. During the day, attendees will get an overview of FDA's OTC drug monograph system, USP's OTC monographs, the larger USP monograph modernization initiative (and FDA's and CHPA's roles in this), and information on progress of FDA's priority monographs of acetaminophen and diphenhydramine. Day two of the workshop will focus on the future of USP monographs for OTC products, including FDA expectations, industry challenges and different approaches for monograph development to allow USP to keep current with advances in the industry. Impurities in OTC drugs will also be a major topic for the day.

Registration for the workshop is $595 for industry and $495 for academia, association and government, with discounts for groups, students and USP Expert Committee members. USP will host a pre-workshop course, "Understanding the USP Compendial Process: Monographs, General Chapters and General Notices," which is recommended for attendees who are not familiar with USP's standards-setting process. Bundled discount pricing is available for those who choose to take the course along with the workshop.


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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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