Elizabeth Trentacost | People

Elizabeth Trentacost counsels life sciences and consumer products companies on a broad range of FDA regulatory, compliance, enforcement, and strategic matters. Elizabeth routinely advises on medical product applications and strategy, product development, submissions to and engagement with FDA, good clinical practices, post-marketing issues, and FDA policy development. She also frequently assists pharmaceutical companies with regulatory inspections and responding to FDA Form 483s and warning letters, especially regarding current good manufacturing practices issues. Elizabeth maintains an active pro bono practice.

Prior to joining Arnold & Porter, she spent several years as a Regulatory Counsel in the Office of Regulatory Policy in FDA's Center for Drug Evaluation and Research. At FDA, she was involved in a wide variety of policy issues involving drug approvals, responded to citizen petitions, developed guidance for industry, and counseled on matters relating to Hatch-Waxman marketing exclusivities. Previously, Elizabeth worked at a law firm in Washington, D.C. where she focused on international trade investigations and appellate litigation.

Focus Areas

Experience

Pharmaceutical companies in preparing for and responding to FDA inspections, including FDA Form 483s and warning letters.
Pharmaceutical companies in recalls and FDA compliance actions, including warning letters and import actions.
Major pharmaceutical company in FDA regulatory issues arising out of an antitrust pay-for-delay lawsuit.
Pharmaceutical company in an extensive internal investigation regarding safety data in an FDA submission.
Trade association in cannabis policy and FDA regulatory issues, including rescheduling.

Private equity firms in acquisitions of medical product and food companies.
Hemp manufacturer in the development of FDA policy regarding cannabidiol.
Cosmetic manufacturer on MoCRA implementation and promotional claims.
Major trade associations in the development of FDA compliance and inspection policy.
Food additive manufacturer in a GRAS submission.
Advises on pre- and post-market development and strategic considerations, including, clinical trials, marketing exclusivity, manufacturing and supply chain, data integrity, review pathways, expanded access issues, and interaction with FDA.
Performs regulatory due diligence on behalf of regulated companies and potential investors or purchasers in connection with commercial transactions involving food and life sciences companies.
Analyzes legislation, regulations, and guidance for industry, drafts comment letters on proposals, and advises FDA-regulated companies on the implications of these developments.
Reviews and advises on quality agreements and contracts, particularly for clinical trials and manufacturing.
Advises on regulatory disclosures for Securities and Exchange Commission filings.
Counsels food companies on FSMA compliance, GRAS status and food additive regulation issues, launching new products, product claims and labeling, marketing campaigns, and FDA policies and guidance.
Reviews labeling and advertising claims for food, cosmetic, drug, and device products, and advises on claims substantiation and risk.
Assists pharmaceutical and medical device manufacturers with promotional review matters and serves as the legal representative on promotional review committees.
Assists pharmaceutical companies in compliance matters, including drafting policies, procedures, and training materials.
Represents companies in advertising challenges before the National Advertising Division (NAD) of the Advertising Self-Regulatory Council.