Precision’s Kohler, Quigley, Guennel on Meeting FDA Specialty Lab Data Requirements


With increased biomarker and specialty lab data being incorporated into FDA submissions, drug developers are running into challenges as they prepare data that comply with new regulatory requirements. Precision for Medicine’s Jared Kohler, Angela Quigley, and Tobias Guennel identify the obstacles and solutions to overcome them.

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Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.