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DMETS Evaluation of Proprietary Names

DMETS Evaluation of Proprietary Names. June 26, 2003. Jerry Phillips, RPh Associate Director Office of Drug Safety CDER. PRE-MARKETING EVALUATION. Begin Review at the End of phase II of an IND and 90 days prior to approval of NDA Proprietary Name Analysis

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DMETS Evaluation of Proprietary Names

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  1. DMETS Evaluation of Proprietary Names June 26, 2003 Jerry Phillips, RPh Associate Director Office of Drug Safety CDER

  2. PRE-MARKETING EVALUATION • Begin Review at the End of phase II of an IND and 90 days prior to approvalof NDA • Proprietary Name Analysis • Expert Panel Review • Verbal and Handwritten Rx studies • Computer-Assisted Analysis • Labeling and Packaging Analysis • Container, Carton, Package Insert, and Proposed Packaging Configuration • Overall Risk/Benefit Evaluation • Written Recommendation provided to Division

  3. WHAT IS DMETS LOOKING FOR? • Sound-alike/Look-alike: • To currently marketed drug names • To other Medicinal Products • To commonly used medical abbreviations, medical procedures, and/or lab tests

  4. Contributing Factors for Name Confusion • Similar indications • Same patient population • Identical formulations • Overlapping strengths or directions • Stored in same areas

  5. Request for Proprietary Name Consult Computer Analysis DMETS Expert Panel Product Sponsor Reviewing Division Project Manager Requests Name Project Manager Consult RXSTUDY Name Studies Safety Evaluators Team Leaders Decision Made Deputy Division Dir Office of Drug Safety Recommendation

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