Judith L. O'Grady

Judy leads the firm’s FDA regulatory team. She advises 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 (FDA). Judy counsels clients on the full range of issues they face in areas such as OTC monographs, INDs, NDAs, 505(b)(2)s, BLAs, 510ks, de novo applications, PMAs, facility registration, product listings, product labeling, good manufacturing practices, clinical trials, adverse event reporting, recalls, inspections, and audits. She also counsels cosmetic, dietary supplement and food companies regarding FDA regulatory compliance. Judy has extensive experience reviewing marketing and promotional materials under FDA and FTC regulations and guidance for a wide range of regulated products, including drugs, medical devices, foods, cosmetics, and dietary supplements.

Judy guides clients on all aspects of responding to FDA enforcement actions, assisting in responses to Warning, Untitled and Complete Response Letters, 483s, 4003s, and FDA import holds. She also provides support to her litigation and white collar colleagues on cases and investigations involving allegations of FDA regulatory violations.

In addition to her counseling work, Judy assists clients on their corporate filings and key transactions. She prepares the regulatory sections of SEC filings and other transaction documents, and leads due diligence teams in conjunction with securities offerings, mergers and acquisitions, asset and stock purchase agreements, and a wide variety of other life science transactions.

Judy’s practice also spans compliance counseling for clinical laboratories related to the Clinical Laboratory Improvements Amendments of 1988 as well as state clinical laboratory laws and regulations. As chair of the Defense Research Institute’s Medicare Secondary Payer Task Force, she also counsels a diverse range of clients on compliance with the Medicare Secondary Payer Act and Section 111 of the Medicare, Medicaid, and SCHIP Extension Act of 2007.

Judy draws from her background as a litigator for pharmaceutical and medical device manufacturers to preemptively identify and address FDA regulatory issues that may present an issue in future litigation. She has experience with all aspects of state and federal litigation, including pre-litigation risk assessments, document collection and production, preparing company witnesses, developing experts, and deposing parties, key witnesses and experts. Before transitioning to her counseling practice, Judy worked on pharmaceutical and medical device product liability federal multidistrict (MDL) litigations, state consolidated matters, and individual plaintiff cases appearing in numerous state and federal courts throughout the United States.

Judy’s medical research and scientific background enables her to firmly grasp the complex scientific issues involved in representing pharmaceutical and medical device manufacturers. She 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 illnesses. Judy also spent time as a laboratory technician in the Anesthesiology Department of the Hospital of the University of Pennsylvania.

• Named a “Rising Star” by Washington, D.C. Super Lawyers (2014-2016)