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Stephanie Resnik is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device Practice Group. She advises pharmaceutical, medical device, biotechnology, food, and tobacco companies on a variety of regulatory and compliance issues, including labeling, advertising, facility registration, CGMP compliance, and reporting requirements.

Ms. Resnik has experience counseling clients on interactions with federal and state regulatory agencies, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC), and state Boards of Pharmacy, as well as interactions with the Better Business Bureaus' (BBB) National Advertising Division (NAD). She has extensive experience working with state regulators and navigating complex state laws and regulations to determine the appropriate licenses or permits required to operate in such states.

  • Advise pharmaceutical companies regarding risks of engaging in various communications regarding investigational products.
  • Prepare citizen petitions for pharmaceutical companies addressing labeling carve-outs.
  • Advise device company regarding risks of promoting device products for specific indications under a 510(k) clearance with a general indication.
  • Conduct regulatory due diligence for mergers, acquisitions, and public offerings involving pharmaceutical, medical device, and food companies.
  • Analyze state and federal regulatory compliance issues for pharmaceutical companies with respect to manufacturing, distribution, reporting, and other requirements.
  • Prepare public comments to FDA on behalf of tobacco companies urging FDA to modify its interpretation and implementation of the Substantial Equivalence pathway for tobacco products.
  • Advise e-cigarette companies on risks of making claims on marketing materials under the Tobacco Control Act's modified risk provisions.
  • Navigate the various federal and state licensing/permitting requirements for food manufacturer's facilities.
  • Advise food companies on the labeling and advertising of food products, including nutrition facts labeling requirements.
  • Counsel tobacco companies on the impact of the Deeming Rule on previously unregulated tobacco products, including registration and listing requirements, health warning requirements, and requirements for obtaining marketing orders.
  • Prepare public comments to USDA on behalf of food manufacturer regarding National Bioengineered Food Disclosure Standard proposed rule.

Pro Bono

  • Advised nonprofit organization on legal issues relating to Washington, DC’s status as a Sanctuary City.
  • Advised nonprofit organization on the authority of the Centers for Disease Control and Prevention (CDC) to research the causes and prevention of gun violence.