Adam Donat

Adam Donat is an Of Cousel in the Food & Drug Administration (FDA) subgroup of the Regulatory and Government Affairs practice at DLA Piper. He leverages his nearly two decades of experience from both inside FDA and working in regulated industry to successfully advise clients on issues related to FDA-regulated products.

Adam has 14 years of experience working in FDA, holding leadership positions for regulatory compliance programs in both the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). These leadership roles focused on clinical trial compliance, and he has in-depth experience directing inspections, managing violative cases (e.g., warning letter cases), and assessing corrective actions. He also has exposure to FDA inspections from the other side of the fence, having undergone inspections while working in regulated industry.

In addition to his regulatory compliance skillset, Adam was heavily involved in numerous high-profile efforts at FDA including Real World Evidence, ClinicalTrials.gov, and expedited review programs such as Breakthrough and the Safer Technologies Program (STeP).

During his time at FDA, Adam gained extensive experience working with FDA review groups and drug/device/biologic companies to address difficult policy issues that arise during FDA review. He has a strong understanding of the challenges faced by both FDA and industry, and leverages his strengths in diplomacy and negotiation to help bring these issues to positive resolution.

Adam Donat focuses his practice on FDA Regulatory, Life Sciences, and Regulatory & Government Affairs.