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News from the FDA

By ALM Staff | Law Journal Newsletters |
October 07, 2003

Collection of Race and Ethnicity Data

The FDA has published a draft Guidance for Industry to recommend categories for collecting effectiveness and safety data during clinical trials for ethnic and racial demographic groups.

FDA regulations require drug sponsors to present an analysis of data according to age, gender and race. An analysis of modifications of dose or dosage intervals for specific groups is also required when manufacturers submit a new drug application for approval by FDA. To accomplish this, the FDA recommends that the drug manufacturers use the Office of Management and Budget (OMB) race and ethnicity categories during clinical trial data collection to ensure consistency in evaluating potential differences in drug response among racial and ethnic groups.
Although the regulations governing medical devices do not include requirements for the collection of demographic data comparable to those for drugs, for those cases in which race and ethnicity data are necessary to determine the safety and effectiveness of a device, FDA encourages sponsors to collect the data in accordance with the OMB information collection standards discussed in this guidance document. Sponsors are also encouraged to discuss any race or ethnicity issue with the appropriate review division within the Office of Device Evaluation, Center for Devices and Radiological Health, when developing their study protocols.
An FDA Talk Paper on
the subjects can be found at: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01193.html.

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