Judy counsels prescription and over-the-counter pharmaceutical, biologic, biosimilar, and medical device companies on a wide variety of complex regulatory issues governed by the Food and Drug Administration.
Judy leads the firm's FDA regulatory team. She counsels prescription and over-the-counter pharmaceutical, biologic, biosimilar, 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 OTC monographs, INDs, NDAs, 505(b)(2)s, BLAs, 351(k)s, 510ks, de novo applications, PMAs, facility registration, product listings, product labeling, good manufacturing practices, clinical trials, adverse event reporting, recalls, inspections, and audits. Judy has extensive experience reviewing marketing and promotional materials under FDA and FTC regulations and guidance. Judy has assisted clients in responding to Warning, Untitled and Complete Response Letters, 483s, 4003s, 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 prepares the regulatory portions of SEC filings, as well as leads the team that conducts due diligence in conjunction with securities offerings, mergers and acquisitions, asset and stock purchase agreements, and a wide variety of other life science transactions. She also supports her litigation and white collar colleagues in cases and investigations involving allegations of FDA regulatory violations.
Judy is currently the vice chair 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.
Judy began her career defending pharmaceutical and medical device manufacturers in products liability actions. She has experience with all aspects of litigation, including pre-litigation risk assessments, document collection and production, preparing company witnesses, developing experts, and deposing key witnesses. Her experience includes work on federal multidistrict litigations, state consolidated matters, and individual state and federal cases. Judy has appeared on behalf of pharmaceutical manufacturers in state and federal courts. This experience allows her to preemptively identify FDA regulatory issues that may present an issue in future litigation and proactively address them.
Judy leverages her deep industry knowledge to help clients mitigate risk by conducting compliance and litigation risk assessments, developing and refining compliance programs, and preparing policies and procedures.
Before entering the legal profession, Judy served as a laboratory assistant at the Stanley Laboratory of Brain Research in Bethesda, MD, 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.
Representative matters may include engagements before joining Troutman Pepper.
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