FDA ge­netic test­ing

Pharmacy Daily - - NEWS -

THE US Food and Drug Ad­min­is­tra­tion has an­nounced a new re­view path­way for con­sumer­fac­ing ge­netic test­ing, say­ing the new tech­nol­ogy presents “unique chal­lenges to FDA reg­u­la­tion”.

Af­ter a six month trial, the FDA has de­cided to im­ple­ment a novel reg­u­la­tory ap­proach which al­lows ge­netic health risk (GHR) tests to be ex­empted from pre­mar­ket re­view un­der cer­tain con­di­tions.

Cer­tain tests which eval­u­ate vi­ta­min D lev­els and ge­netic car­rier screen­ing tests will also be ex­empted from pre­mar­ket re­view more de­tails at www.fda.gov.

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