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The compound itself was identified in 1998 in gastric juices

For context, the first-trimester miscarriage rates are greater in some of the drug groups studied, for example, 29 percent compared to 13 percent in controls, and congenital abnormality rates differ between cohorts

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We sought comments on whether these products should meet a substantial clinical improvement standard or whether, consistent with current pass-through policy, a device that has received marketing authorization for an indication covered by FDA's Breakthrough Devices Program would generally represent clinically-relevant innovation sufficient to qualify for a product-specific payment rate