Latham litigation team recognized for successful appeal to the 11th Circuit on behalf of Catalyst in dispute with FDA.
Food and Drug Administration (FDA)
Leading companies and global market leaders in the medical device, pharmaceutical, biotechnology, cosmetic, tobacco, food, and dietary supplement industries need to know what to expect when interacting with the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Federal Trade Commission (FTC), and Department of Health and Human Services (HHS), including how to:
- Bring cutting-edge products to market, while leveraging experience in pre-market product development, market exclusivity strategies, pre-clinical and clinical testing, product submissions, and approvals
- Successfully navigate labeling, marketing and promotion, and good manufacturing practice requirements
- Successfully resolve agency inspections, recalls and other high-stakes enforcement actions, at the negotiating table, in formal administrative hearings, and in federal court
When serving clients on these and other difficult or cutting-edge matters involving the FDA, DEA, HHS, FTC, and Congress, Latham’s FDA Regulatory has the institutional experience and insight to produce successful outcomes; whether by placing the right call or, if necessary, litigating through trial. In Washington, the team includes lawyers who previously held the following government positions:
- General Counsel of HHS
- Assistant Attorney General for the United States Department of Justice (DOJ) Criminal Division
- Principal Deputy Assistant Attorney General for the United States DOJ Civil Division
- General Counsel of United States Office of Management and Budget (OMB)
- Majority Counsel of the United States House of Representatives Energy and Commerce Committee
- A Senior Counsel in the DHHS Office of Inspector General (OIG)
- Attorney in the General Counsel’s Office of the United States Center for Medicare and Medicaid Services (CMS)
Market-leading advice in key litigation, regulatory and transactional areas recognized.
For serving as lead counsel in a dispute that prompted a rare formal withdrawal of an FDA warning letter, John Manthei, co-chair and Washington, D.C. chair of the Healthcare & Life Sciences Practice, is honored as a Life Sciences MVP.