Jacqueline Berman advises companies throughout the US Food and Drug Administration (FDA)–regulated product supply chain on regulatory and compliance requirements. Jacqueline helps clients navigate complex issues associated with development, approval, and commercialization of prescription and non-prescription pharmaceuticals and biologics, including vaccines, and cell and gene therapies. Jacqueline further counsels clients on legal requirements under laws enforced by the US Consumer Product Safety Commission, Federal Trade Commission, US Drug Enforcement Agency, and state licensing agencies for consumer products, controlled substances, pharmaceuticals, and medical devices.
Jacqueline partners with clients, assisting them in obtaining FDA approval for regulated products, launching such products in the market, and maintaining legal and regulatory compliance, to ensure that new and existing treatments can be provided to the patients that need them. This includes counseling on regulatory pathway and expedited development strategies, interacting with regulatory authorities, and advising on clinical and pre-clinical trial conduct, research ethics, product manufacturing and quality, product distribution, and product labeling, promotion, marketing, and advertising.
Jacqueline further assists companies facing regulatory crises and challenges, such as inspectional deficiencies, FDA Untitled and Warning Letters, recalls, and other enforcement actions, as well as competitor trade complaints and internal investigations.
Jacqueline works with a variety of clients, including established and start up biopharmaceutical sponsors and manufacturers, third-party logistics providers, wholesale distributors, pharmacies, and retailers. In addition to her FDA practice, Jacqueline assists manufacturers, distributors, and dispensers of controlled substances and listed chemicals to understand and comply with DEA and state requirements.
Jacqueline is 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 was named a US Rising Star, Regulatory by the LMG Life Sciences Awards Americas.
Recommended, Industry focus: Healthcare: life sciences, The Legal 500 US (2022)
Life Sciences Star, FDA: Medical Device, LMG Life Sciences Awards Americas (2023)
Life Sciences Star, FDA: Pharmaceutical, LMG Life Sciences Awards Americas (2023)
Life Sciences Star, Regulatory, LMG Life Sciences (2021, 2022)
US Rising Star, Regulatory, LMG Life Sciences Awards Americas (2021)
Member of Food and Drug Law Institute Clinical Trials Conference Planning Committee (2022)
Member of Food and Drug Law Institute Webinar Committee (2021)
Member of Food and Drug Law Institute Editorial Committee (2018–2019)