Jacqueline R. Berman

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.  

• Assisted in responding to FDA, DEA, and state enforcement actions, including inspectional findings and assertions of non-compliance
• Supported numerous biopharmaceutical companies in initial public offerings, re-offerings, public filings, and merger and acquisition transactions, including regulatory due diligence, agreement negotiation, and drafting filings
• Supported multiple companies seeking marketing approval of innovative and new biopharmaceutical products in their interactions, submissions, and negotiations with FDA
• Assisted OTC, dietary supplement, and medical device manufacturers in the review and establishment of internal quality and compliance programs
• Advised numerous companies on regulatory issues and questions concerning pre-clinical and clinical product development, including compliance with good clinical practices, conflicts of interest, NIH grants and compliance requirements, subject informed consent, and institutional review board approval
• Counseled numerous companies on regulatory pathways and life cycle management strategies, including orphan drug designations, fast track designations, accelerated approvals, breakthrough therapy designations, regenerative medicine designations, regulatory exclusivity, and patent term extension
• Advised companies developing new and innovative therapeutic technologies, including cell and gene therapies, as well as companies using new development and manufacturing technologies, including artificial intelligence on FDA-regulatory requirements, pathways, and options
• Drafted and negotiated agreements for all levels of the life sciences supply chain, including manufacturing, quality, distribution, purchase and supply, and clinical trial agreements
• Assisted companies in understanding and developing systems and processes to comply with evolving legal and regulatory requirements, including requirements under the Drug Supply Chain Security Act and the Controlled Substances Act