In the August 22, 2014, Federal Register, FDA announced the availability of the action plan required by Section 907 of the Food and Drug Safety and Innovation Act ("FDASIA") and the reopening of a public docket for comments on the action plan. Section 907 requires FDA to report on and address certain information regarding clinical trial participation by demographic subgroups and subset analysis of the resulting data. The required report was posted on FDA's website in August 2013. Section 907 also requires FDA to publish an action plan containing recommendations to improve the completeness and quality of analyses of data on demographic subgroups. FDA is reopening the docket for 60 days to provide an opportunity for the public to submit comments on the action plan. Comments due October 21, 2014.
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