Jeremiah Kelly’s practice centers on helping companies navigate the complexities of the U.S. Food and Drug Administration’s (FDA) regulation of drugs, biologics, medical devices, and combination products. Jeremiah helps companies from “bench to bedside.” He supports companies along the development and commercialization pathway, from pre-clinical, clinical, and pre-market applications for FDA’s approval, licensure, clearance, or authorization of medical products to post-market compliance. Prior to joining Venable, Jeremiah served as the Chief of the FDA Regulatory Law Division in the Office of the Staff Judge Advocate (JAG), U.S. Army Medical Research and Development Command (USAMRDC).
Jeremiah’s practice includes overall regulatory strategy, support to investigational new drug applications (INDs) or investigational device exemptions (IDEs), support to pre-market applications (505(b)(1) and (b)(2) NDAs, BLAs, EUAs for drugs and biologics as well as 510(k)s, PMAs and De Novo Requests for medical devices), GxPs, expedited approval mechanisms, Hatch-Waxman and BPCIA regulatory frameworks, regulatory incentives (e.g., marketing exclusivity and priority review vouchers), product labeling, risk evaluation and mitigation strategies (REMS), advertising and promotion, response to FDA compliance actions (e.g., negative 482 or Warning Letters), input and challenges to FDA rulemaking under the Administrative Procedures Act (APA), and helping companies shape legislative changes to the Federal Food, Drug, and Cosmetic (FD&C) Act and the Public Health Service Act (PHSA).
Jeremiah’s practice also includes unique expertise in agreements with the research and development (R&D) elements of the Federal government. He has drafted and negotiated cooperative research and development agreements (CRADAs), Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation (DFAR) contracts, grants and cooperative agreements, other transaction agreements (OTAs), experimental supply agreements, and patent license agreements to create “win-win” collaborations between industry and the government.
As the Chief of the FDA Regulatory Law Division, JAG, USAMRDC, Jeremiah advised USAMRDC and the Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Nuclear and Radiological Defense (JPEO-CBRND) on the development and regulation of medical countermeasures to treat the unique needs of the U.S. solider. During the COVID-19 pandemic, he served as the Chief Coordinating Counsel of the DoD JPEO-CBRND Joint Assisted Acquisition (JA2) Legal Cell, managing, staffing, and negotiating over $83B in COVID vaccine, therapeutic, and diagnostic capabilities for the Federal Government’s COVID-19 response. Prior to his DOD service, Jeremiah spent over seven years in the FDA Commissioner’s Office in the Office of the Chief Counsel (OCC) and the Office of Legislation (OL) and three years as a litigator at a large private sector law firm.