Jacqueline R. Berman
Jacqueline Berman provides strategic and practical guidance to companies throughout the US Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC)–regulated product supply chain on FDA, CPSC, and US Drug Enforcement Administration (DEA) regulatory and compliance requirements. Jacqueline helps clients navigate high-priority and complex regulatory and legal issues and initiatives, including product development, launches, pathway strategies, responses to regulatory enforcement and inspectional findings associated with the clinical and preclinical studies, approval, manufacturing, sale, and commercialization of prescription and non-prescription pharmaceuticals and biologics, controlled substances, and consumer products.
Jacqueline’s practice spans the pharmaceutical and biologic product lifecycle, including development and clinical trial strategies, post-market compliance, and product commercialization, dispensing, and distribution. Her broad and extensive background includes assisting clients to obtain and maintain FDA approval for regulated products, including after receiving complete response letters; and advising clients on expedited development and rare disease pathways, including accelerated approval, fast track designation, breakthrough therapy designation, medicine advanced therapy designation, priority review, and orphan drug designation, as well as evolving FDA review standards. Jacqueline regularly works with clients to initiate clinical development programs, including multi-regional clinical trials, advising on good clinical practices and research ethics, as well as negotiating clinical trial contracts.
Jacqueline further partners with companies in developing product launch strategies, including compliant promotional and advertising materials, and supports companies in maintaining manufacturing programs that comply with current good manufacturing practices. Jacqueline frequently assists clients in their interactions with FDA, including through informal communications and formal meetings, as well as during moments of crisis, such as following receipt of agency inspectional findings or other enforcement actions, and when making decisions regarding the need for recalls and other field actions.
In addition to her deep FDA regulatory knowledge, Jacqueline also helps companies navigate the regulatory requirements of self-regulatory organizations, such as the National Advertising Division of the Better Business Bureau, and other government agencies, such as the DEA, the CPSC, and state licensing boards. With respect to the CPSC, Jacqueline counsels companies on CPSC labeling and safety standards, reporting requirements, and recalls. With respect to DEA, Jacqueline assists companies navigating the agency’s controlled substance and listed chemical requirements for manufacturers, distributors, investigators, dispensers, and reverse distributors. This includes requirements related to registration, suspicious order monitoring, reporting, compliance, enforcement and inspections, as well as the interaction between DEA and FDA regulation, such as in the area of the development and approval of psychedelic therapies.
Jacqueline is a co-leader of the Morgan Lewis Life Sciences Industry Initiative, and an active member of the Food and Drug Law Institute, having served on numerous committees over the years. Jacqueline is also a frequent writer and speaker on issues facing the life sciences industry. Jacqueline has been named a Life Sciences Star in multiple FDA regulatory areas for multiple years in a row by the LMG Life Sciences Awards Americas.
