Jacqueline R. Berman advises companies on US Food and Drug Administration (FDA) regulatory, compliance, and enforcement issues, as well as clinical trials and FDA-regulated product development programs. She also counsels clients on the safety, labeling, and reporting requirements for consumer products under the laws enforced by the US Consumer Product Safety Commission (CPSC), the Federal Trade Commission (FTC), and related state enforcement agencies. Jacqueline’s clients include pharmaceutical, device, biologic, dietary supplement, and food/food additive manufacturers.
Jacqueline advises clients on product recalls, marketing applications, labeling, marketing and advertising, and privacy issues. She also works with companies on postmarketing obligations including adverse event reporting and compliance with current good manufacturing practices (cGMP).
In her clinical trial work, Jacqueline counsels clients on FDA requirements, contracting, ethics and informed consent, data transfer from international trial sites, data security, and Health Insurance Portability and Accountability Act (HIPAA) privacy and confidentiality.
She previously practiced in an FDA boutique law firm.
American University, 2006, B.A., Summa Cum Laude, Phi Beta Kappa
The George Washington University Law School, 2009, J.D., With Highest Honors
District of Columbia
Awards and Affiliations
Life Sciences Star, Regulatory, LMG Life Sciences (2021)