Challenge A pharmaceutical company faced a critical situation when they reported a seriousadverse event (SAE) for a patient enrolled in their clinical trial. Swift action was neededto respond to the FDA’s questions, safeguard patients, and prevent disruptions to thetrial. However, addressing FDA’s questions presented a formidable challenge because itrequired extensive, non-standard genomic analyses to establish… Read More » Rapid Genomic Analysis Clears FDA Hurdle