Bombard Y, Brothers KB, Fitzgerald-Butt S, et al. Am J Hum Genet. 2019 Apr 4;104(4):578-595. Abstract The evidence base supporting genetic and genomic sequence-variant interpretations is continuously evolving. An inherent consequence is that a variant’s clinical significance might be reinterpreted over time as new evidence emerges regarding
Read more →The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards (IRBs) with information to facilitate the inclusion of adolescent patients (for purposes of this guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the
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