The FDA/Regulatory Group at FLH represents companies in the food, drug, biologic, medical device, or cosmetic and dietary supplement industries. The Group offers 30-plus years of private practice experience, with emphasis on sound judgment, thorough analysis and practical advice.
The FDA/Regulatory Group provides a broad spectrum of services, including pre-market approval applications (NDAs, ANDAs, BLAs, INDs, and NDI notifications), product claims and labeling, product advertising and promotion, good manufacturing practice requirements, FDA inspections, product safety issues, prescription drug user fees, and regulation pertaining to imports and exports. Many of our FDA/Regulatory attorneys are based in our Washington, DC office, which enables interface with the FDA on a regular basis. Some of our FDA/Regulatory attorneys formerly worked in the FDA Chief Counsel’s Office, and therefore possess a more intimate knowledge of agency processes and procedures, and valuable insight on FDA policies.
FLH attorneys are also skilled in conducting administrative and court proceedings in the regulatory arena. Our experience includes leading court challenges to FDA rules and statutory interpretations, crafting responses to FDA warning letters, and addressing FDA inspections, recalls, seizures, criminal proceedings, injunctions, and appeals.
The FDA/Regulatory Group works with and supports FLH’s Hatch-Waxman practice in handling Paragraph IV Certifications, ANDA Requirements or Bioequivalence studies. FLH represents both branded pharmaceutical businesses, and generic pharmaceutical manufacturers.
The depth of experience of our FDA/Regulatory group, coupled with excellent service, makes FLH a proven leader in FDA/Regulatory practice.