Jeremiah J. Kelly

Regulatory Strategy & FDA Submissions

Jeremiah is nationally recognized in FDA law and for his unique depth and breadth in the Agency’s regulation of medical products. He offers comprehensive support for regulatory strategy and product submissions, including investigational new drug (IND) applications, investigational device exemptions (IDEs), and pre-market filings such as 505(b)(1) and 505(b)(2) new drug applications (NDAs), biologics license applications (BLAs), emergency use authorizations (EUAs), 510(k) notifications, premarket approval applications (PMAs), De Novo requests, and compliance with good practice (GxP) standards. He advises clients on expedited approval pathways, Hatch-Waxman and BPCIA regulatory frameworks, incentives like marketing exclusivity and priority review vouchers, product labeling, risk evaluation and mitigation strategies (REMS), advertising and promotion, and responding to FDA compliance actions. Jeremiah also provides counsel on administrative challenges to FDA rulemaking and helps clients shape legislative amendments to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Jeremiah’s experience extends to CMS’ coverage and reimbursement framework and the unique authorities that impact medical countermeasure (MCM) development like DoD’s enhanced engagement authority under PL 115-92 and the Animal Rule.

Government Contracting & Collaboration

Jeremiah’s practice includes a particular focus on research and development collaborations with the federal government, including DoD and HHS BARDA, among others. His work facilitates productive, “win-win” collaborations between industry and government, allowing clients to advance innovation while meeting product development goals, obtaining non-dilutive funding, and satisfying government requirements. Jeremiah strategically guides clients through drafting and negotiating every type of R&D agreement with the federal government, with extensive experience in other transaction agreements (OTAs) (bilateral and consortium approaches), as well as cooperative research and development agreements (CRADAs), Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation (DFAR) contracts, grants and cooperative agreements, experimental supply agreements, and patent license agreements.

Prior Experience

Prior to joining Faegre Drinker, Jeremiah was a partner in the food and drug law practice group at a Washington, D.C.-based firm, where he helped re-establish and lead the firm’s medical products team and advised pharmaceutical, medical device, biotechnology, and combination product companies on FDA-regulated product development issues, coverage and reimbursement, and strategic business collaborations with both private sector and government partners.

Jeremiah brings substantial FDA regulatory experience to his practice, having served in FDA’s Office of the Commissioner for over seven years, serving in both the Office of the Chief Counsel and Office of Legislation. In addition, Jeremiah served as the chief of the FDA Regulatory Law Division within the Office of the Staff Judge Advocate, US Army Medical Research and Development Command (USAMRDC), part of the Defense Health Agency (DHA) for over 12 years. In this DHA role, he also advised US military’s Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (formerly the Joint Program Executive Office for CBRND) on the development and regulation of medical countermeasures tailored to the unique needs of US soldiers.

During the COVID-19 pandemic, Jeremiah served as chief coordinating counsel of JPEO-CBRND Joint Assisted Acquisition (JA2) Legal Cell, where he managed, staffed, and negotiated thousands of actions totaling over $83 billion in R&D contracts and OTAs for COVID-19 vaccines, therapeutics, and diagnostic capabilities as part of the federal government’s pandemic response. In between his FDA and DoD service, Jeremiah was a litigator at a large private sector law firm.

Faculty Positions

• Northeastern University, Master’s Program in Regulatory Affairs, College of Professional Studies — Lecturer, Therapeutic Product Development/Generics & Biosimilars/ Medical Device Development, 2018-present
• Mount St. Mary’s University, Master of Science in Biotechnology and Management Program — Adjunct Professor, Biotechnology & FDA Regulations/Drug and Biologics Compliance/International Regulations, 2016-present

Personal Interests

Outside the office, Jeremiah enjoys serving his community and family in various ways. For over 11 years, he has coached high school, Babe Ruth and Little League baseball in the Frederick, MD area where his boys play ball. He also coaches Upward Basketball in Jefferson, MD for both his daughters and sons. Jeremiah is active in youth ministry and in leadership at his church, the Frederick Church of the Brethren. The smartest thing he’s ever done is marry his high school sweetheart — now married for 24 years, they have five beautiful children. He recently became a “farmer” (air quotes as we are not yet sure if this is an appropriate term) having added angus beef cattle to his farm west of his hometown of Frederick, MD. This is a work in progress.