February 1, 2023

Volume XIII, Number 32

Emily M. Leongini

Emily provides strategic regulatory counsel to companies in FDA-regulated industries.

Emily helps clients understand and mitigate risk as they develop and launch new products, manage commercial relationships, navigate post-market regulatory requirements, and respond to regulatory actions and potential crises.

Since joining ArentFox Schiff from the US Food and Drug Administration (FDA) in 2015, she has helped companies navigate legal and regulatory requirements implemented and enforced by the FDA, US Department of Agriculture (USDA), Federal Trade Commission (FTC), Drug Enforcement Administration (DEA), and their state counterparts.

Emily provides strategic advice and advocacy to small, mid-size, and large companies on a wide range of regulatory, compliance, enforcement, and transactional matters. She works with clients in virtually every FDA-regulated industry, with a particular focus on supporting consumer health, wellness, and beauty product and cannabis/hemp/CBD industries.

Her work includes:

  • Reviewing proposed advertising, labeling, and promotional materials for companies that market medical devices, dietary supplements, conventional foods, cosmetics, and prescription and OTC drugs for compliance with FDA, USDA, and FTC requirements

  • Providing guidance on evolving requirements imposed under the Food Safety Modernization Act (e.g., Foreign Supplier Verification Programs, Hazard Analysis and Risk-Based Preventive Controls)

  • Evaluating proposed ingredients and finished formulations

  • Counseling on compliance with FDA’s OTC monographs (including the recent OTC monograph reforms enacted as part of the CARES Act)

  • Advising on registration and listing, cGMPs, adverse event reporting, and pharmacovigilance

  • Helping clients prepare for and respond to inspections, recalls, warning and untitled letters, and other enforcement actions

  • Providing advice related to importation, exportation, and supply management

  • Serving as the regulatory subject matter expert in consumer and competitor challenges brought under the Lanham Act and state unfair competition/false advertising laws based on product advertising and promotional claims

  • Drafting and analyzing proposed federal and state legislation, regulations, and policy documents, preparing position papers and talking points, and analyzing and responding to proposed regulations and draft guidance documents

  • Conducting regulatory due diligence on behalf of entities investing in and acquiring companies that market FDA-regulated products

  • Drafting, negotiating, and providing guidance related to regulatory aspects of commercial agreements, e.g., agreements related to third-party research, contract manufacturing and suppliers, advertising and sponsorship, and sales and distribution

Emily also provides strategic regulatory counseling to clients in the cannabis/hemp/CBD industries on a wide array of state and federal matters.

Articles in the National Law Review database by Emily M. Leongini

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