JUDITH O’GRADY is a partner at Troutman Pepper Hamilton Sanders LLP where she counsels pharmaceutical and medical device companies on a wide variety of complex regulatory issues governed by the Food and Drug Administration. As part of her FDA counseling practice, she has advised clients regarding INDs, NDAs, 510ks, PMAs, facility registration, product listings, product labeling, good manufacturing practices, clinical trials, adverse event reporting and marketing and promotional claims. Judy has assisted clients in responding to Warning, Untitled and Complete Response Letters, 483s, and FDA import holds. Judy also counsels clinical laboratories regarding their compliance with the Clinical Laboratory Improvements Amendments of 1988, as well as state clinical laboratory laws and regulations. In addition to her counseling work, Judy leads Troutman Pepper’s team of FDA and clinical laboratory regulatory experts in preparing SEC filings, as well as conducting due diligence in conjunction with securities offerings, mergers and acquisitions. Judy is an active member of the Defense Research Institute’s Medicare Secondary Payer Task Force, and counsels clients regarding compliance with the Medicare Secondary Payer Act and Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007. Before entering the legal profession, Judy served as a laboratory assistant at the Stanley Laboratory of Brain Research in Bethesda, Maryland, where she researched the normal development of the brain and the neuropathology of major mental illness. She also spent time as a laboratory technician in the Anesthesiology Department of the Hospital of the University of Pennsylvania. Judy’s medical research background gives her a strong grasp of the complex scientific issues involved in representing pharmaceutical and medical device manufacturers.