SEEK­ING DATA

Modern Healthcare - - THE WEEK IN HEALTHCARE - Source: U.S. Food and Drug Ad­min­is­tra­tion

The FDA con­sid­ers fe­cal trans­plants— used to fight deadly C. diff in­fec­tions— “in­ves­ti­ga­tional new drugs.” Here’s some of what doc­tors who use them must sub­mit: ● Gen­eral in­ves­ti­ga­tional plan

● Avail­able sup­port­ing data

● De­tailed clin­i­cal pro­to­cols

● In­ves­ti­ga­tor in­for­ma­tion

● Com­mit­ment to ob­tain in­formed con­sent for the re­search sub­jects

● Com­mit­ment to ob­tain re­view by an in­sti­tu­tional re­view board

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