- Counsel clients on Emergency Use Authorization vaccine distribution matters
- Counsel clients regarding FDA regulatory matters to facilitate bringing new products and processes into the marketplace; including navigating FDA regulatory interactions and making determinations regarding whether products are cleared, subject to an exemption, or require a formal filing with the agency
- Advise on regulatory disclosures and review of drug and device company therapeutics and technologies during initial public offerings
- Counsel on the regulatory terms of a range of commercial contracts, including quality agreements
- Advise drug developers on regulatory compliance requirements related to clinical and quality issues that arise during the product development stage
- Work closely with scientists and outside laboratories in conducting safety and technical suitability analyses necessary to get products onto the market
Mr. Gitner has been providing counsel to FDA regulated companies for the past two years, focusing on establishing the suitable FDA regulatory status of various products and procedures, with clients ranging from large corporations to trade organizations.
Before joining Goodwin, Mr. Gitner was an associate with Keller and Heckman LLP’s FDA regulatory practice. While in law school, Mr. Gitner was a Lead Civil Intern for the D.C. Superior Court where he conducted legal research and edited and reviewed motions and memoranda. In addition, he was a member of Georgetown’s Environmental Law Review, served as the co-president of Georgetown’s Food Law Society, and was a board member of the National Food Law Student Network.
After receiving his bachelor’s degree, Mr. Gitner was a legal assistant for a litigation firm where he researched and compiled discovery documents for the attorneys in preparation for depositions and trials. Prior to his tenure at the litigation firm, Mr. Gitner served as an intern on Capitol Hill and in the government relation’s arm of a government agency.
Mr. Gitner is a member of the Food and Drug Law Institute as well as the Virginia Biotechnology Association (Virginia Bio).