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Brand Names In 2008: Can Industry Pilot Its Way Out Of Trouble?

Executive Summary

Industry may shoulder some of the burden of testing proprietary drug names this year under a pilot program included in the renewal of the Prescription Drug User Fee Act, but with that may come some clarity in a subjective field that so far has lacked detailed guidance from FDA

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Trade Name Review May Shift To Firms, But FDA Unclear Which Tests To Use

FDA is asking firms to use computerized methods and algorithms that can detect product name similarities as part of a pilot designed to expedite name review. The program, under which companies would generate their own data and submit it to FDA for review, will be discussed at a June 5-6 public meeting

Trade Name Review May Shift To Firms, But FDA Unclear Which Tests To Use

FDA is asking firms to use computerized methods and algorithms that can detect product name similarities as part of a pilot designed to expedite name review. The program, under which companies would generate their own data and submit it to FDA for review, will be discussed at a June 5-6 public meeting

CDER/CBER proprietary names meeting

CDER and CBER will hold a public meeting June 5 to prepare for a pilot program on enabling pharmaceutical firms to evaluate proposed proprietary names and submit data generated from those evaluations to FDA for review (1"The Pink Sheet," Jan. 14, 2008, p. 15). The agenda includes a concept paper describing the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review and the way FDA intends to review submissions. FDA plans to issue the concept paper by the end of this fiscal year and begin the pilot in FY 2009

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