FDA May Revise MedWatch Reporting Methods For Race, Ethnicity Data
Executive Summary
FDA is considering revising the way patient race and ethnicity data are collected on MedWatch adverse event reporting forms
You may also be interested in...
Pediatric Trial Sponsors Should Report Minority Enrollment, GAO Says
FDA should require drug sponsors conducting pediatric trials to use specific categories in reporting the race and ethnicity of participants, GAO said
FDA Race/Ethnicity Data Categories Should Use Global Definitions – PhRMA
FDA should use global definitions to set categories for collection of race and ethnicity data in clinical trials, the Pharmaceutical Research & Manufacturers of America said
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011