Brian P. Waldman
Brian P. Waldman is a member of Arent Fox's Executive Committee, co-manager of the firm’s Regulatory Department, and a member of the department’s Food & Drug Group. Brian concentrates his practice in the area of food and drug law and advertising law, counseling clients primarily on pharmaceutical, medical device, food, dietary supplement and cosmetic issues, with particular emphasis on developing effective strategies for introducing new products.
Brian advises clients on a broad range of legal and regulatory issues in all phases of a product’s life cycle, including (i) developing appropriate strategies for the introduction of new ingredients and finished products, (ii) coordinating pre-market safety, efficacy, and claims evaluations, (iii) preparing FDA-related applications and notifications, (iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials, (v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and (vi) responding to threatened enforcement action. He has counseled clients in all stages of product development, from pre-clinical trials through post-marketing studies. As part of this work, Brian has coordinated interactions between product developers, contract research organizations, site management organizations, institutional review boards, investigators, and the FDA.
Much of Brian’s practice involves crisis management support. Brian assists clients in preparing for and during government investigations, as well as in evaluating and responding to adverse product information. He has coordinated numerous recalls, market withdrawals, and other product corrective actions.
Brian conducts regulatory compliance audits to ensure that both product manufacturers and distributors are in full compliance with applicable laws and regulations. Further, he has drafted proposed federal and state legislation in support of the interests of manufacturers and distributors and represented these interests before legislators and regulators.
Brian works extensively with attorneys in the firm’s Health Group, Intellectual Property Group, and Corporate Transactional Group. He has negotiated numerous licensing, supply and distribution agreements; conducted numerous due diligence audits of acquisition targets; prepared regulatory compliance opinions in support of public offerings; and supported food and drug-related litigation.
Publications, Presentations and Recognitions
Brian recently co-wrote a chapter on dietary supplements in the Food and Drug Law Institute's “Food and Drug Law and Regulation.” He also co-wrote an article titled “Cosmeceuticals: The Legal Problem and Feasible Solutions,” published in The Food, Drug, Cosmetic, and Medical Device Law Digest. He frequently lectures on food and drug approval and regulatory compliance issues for the Food and Drug Law Institute, the Biotechnology Industry Organization, the Center for Professional Advancement, the American Conference Institute, and other seminar sponsors.
Brian was recognized in the 2014 edition of The Best Lawyers in America.