Seth Gitner

Seth Gitner

Associate

Contact Info

Phone: (202) 295-6641

Primary Office

Washington
1919 Pennsylvania Avenue, N.W.
Suite 550
Washington, DC 20006-3434

Seth Gitner

Associate

Seth Gitner

Seth Gitner counsels clients on regulatory, compliance, enforcement and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), the U.S. Drug Enforcement Administration (DEA) and myriad state agencies. Companies in the cannabis (both hemp and marijuana), consumer health care products, life sciences, food and beverage, cosmetics and tobacco industries, among others, turn to Seth for advice on how to get and keep their products on the market. From product development to initial public offerings, Seth helps clients navigate regulatory considerations through the stages of development, including agency interactions and regulatory due diligence. He has experience working closely with scientists and outside laboratories to conduct safety and technical suitability analyses necessary to support initial and continued product marketing. His experience includes:

  • Drafting and revising promotional materials, press releases and public filings with the U.S. Securities and Exchange Commission (SEC).
  • Authoring opinion letters on suitable marketing pathways and preparing FDA submissions related to the same.
  • Drafting and negotiating regulatory terms in a variety of commercial agreements.

While in law school, Seth was the lead civil intern for Judge Michael Rankin of the D.C. Superior Court. Before law school, Seth was also a Congressional intern for then-House Democratic Leader Nancy Pelosi, and was a government relations intern for the Corporation For National and Community Service (CNSC). While at CNSC, he prepared staff members for, and participated in meetings with members of Congress and their aides.

Experience

Select representations include:

  • A client related to Emergency Use Authorization (EUA) vaccine distribution matters during the COVID-19 pandemic.
  • A client seeking to establish a suitable marketing pathway for biodegradable polymers used in various food-contact applications.
  • A next-generation biopharmaceutical company in a $250 million financing.
  • A purchaser in a $200 million private offering for a market-stage biopharmaceutical company.
  • A clinical-stage pharmaceutical company in a successful initial public offering (IPO), through which the company raised proceeds of approximately $150 million.
  • A leading biotechnology company in an at-the-market (ATM) offering providing the sale of up to $150 million of the company’s stock.
  • Underwriters in a $115 million follow-on offering for a clinical-stage biopharmaceutical company.

Thought Leadership

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Credentials and Accolades

Education

J.D., Georgetown University Law Center, 2018

B.A., University of Colorado Boulder, 2010

Bar Admissions

District of Columbia

Seth Gitner counsels clients on regulatory, compliance, enforcement and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA), the U.S. Drug Enforcement Administration (DEA) and myriad state agencies. Companies in the cannabis (both hemp and marijuana), consumer health care products, life sciences, food and beverage, cosmetics and tobacco industries, among others, turn to Seth for advice on how to get and keep their products on the market. From product development to initial public offerings, Seth helps clients navigate regulatory considerations through the stages of development, including agency interactions and regulatory due diligence. He has experience working closely with scientists and outside laboratories to conduct safety and technical suitability analyses necessary to support initial and continued product marketing. His experience includes:

  • Drafting and revising promotional materials, press releases and public filings with the U.S. Securities and Exchange Commission (SEC).
  • Authoring opinion letters on suitable marketing pathways and preparing FDA submissions related to the same.
  • Drafting and negotiating regulatory terms in a variety of commercial agreements.

While in law school, Seth was the lead civil intern for Judge Michael Rankin of the D.C. Superior Court. Before law school, Seth was also a Congressional intern for then-House Democratic Leader Nancy Pelosi, and was a government relations intern for the Corporation For National and Community Service (CNSC). While at CNSC, he prepared staff members for, and participated in meetings with members of Congress and their aides.