John Manthei

Practice Areas

John Manthei, Global Chair of the Healthcare & Life Sciences Practice, focuses his practice on regulatory matters involving the US Food and Drug Administration (FDA) for the medical device, pharmaceutical, and biotechnology industries.

Mr. Manthei’s practice includes assisting clients with all aspects of the FDA-regulated product life cycle, including, among others:

• Pre-market development

• FDA product submissions

• Development of market exclusivity strategies

• Drafting and negotiation of both US and international clinical trial agreements

• FDA and Federal Trade Commission (FTC) regulation of marketing and promotion of products

• Quality System Regulation and Good Manufacturing Practice requirements (including assisting in third-party audits and drafting SOPs)

• FDA inspections; recalls

• FDA and DEA export and import requirements

• Civil and criminal compliance and enforcement

Mr. Manthei has also been involved extensively in Administrative Procedures Act litigation, including successfully challenging the Agency in Catalyst Pharmaceuticals v. FDA, Eagle Pharmaceuticals v. FDA, Pacira Pharmaceuticals v. FDA, Endo/Par Pharmaceuticals v. FDA, Genus Medical Technologies v. FDA, Sottera/NJOY v. FDA, and Commonwealth v. FDA, as well as successfully intervening to defend FDA actions on behalf of clients in Teva v. FDA, Weyth Pharmaceuticals v. FDA, and Athenex v. FDA.