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FDA calls for standardised racial and ethnic data

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7383.244/b (Published 01 February 2003) Cite this as: BMJ 2003;326:244
  1. Deborah Josefson
  1. Nebraska

    The US Food and Drug Administration has asked drug manufacturers to integrate race and ethnicity data into their analyses of new drugs by using the same general classifications used in other government data collection systems.

    An analysis of drug dosage and interval modifications by age, race, and sex is also required in new drug applications.

    The FDA currently requires drug sponsors to present safety and effectiveness data by age, race, and sex but does not specify how this is to be done. The new guidelines have asked companies to use the same broad categories established …

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