Michael Best’s broad-based FDA Regulatory practice covers the full gamut of matters related to the U.S. Food and Drug Administration (FDA) and other product regulation agencies. Whether a client’s product is food, drugs, medical devices, software, cosmetics, dietary supplements, or lasers, we have the experience to match.
Our FDA Regulatory group is multidisciplinary and cross-practice. Not only do we have the right attorney for any FDA matter, but we also collaborate across practice groups to integrate sound FDA regulatory advice into projects involving our intellectual property, environmental, and corporate groups, among others. We assist clients throughout the entire product life cycle, starting with premarket services such as:
- Product classification and developing regulatory strategies
- Preparing and prosecuting full premarket submissions for various product types (see “Industry Experience” below)
- Reviewing design control and product validation programs
- Registration, listing, and prior notice for imports
Once a product goes to market, we continue to counsel clients in matters such as:
- Production – Current Good Manufacturing Practices, Quality Systems, Hazard Analysis and Critical Control Points, and Hazard Analysis and Risk-Based Preventive Controls
- Safety – Adverse event reporting, Postmarket Surveillance Studies, Post-Approval Studies, and Risk Evaluation and Mitigation Strategies
- Compliance and enforcement – Self-audits, employee and management training, inspections, recalls, warning letters, and enforcement actions
Our experience spans both FDA and industry, giving us an in-depth understanding of the thinking behind regulatory decisions, combined with practical business know-how. The head of our FDA Regulatory practice spent 14 years at FDA, for example, and other attorneys in our group have worked in FDA-regulated businesses.
Because of our wide-ranging experience, we can readily advise on issues that cross over product types, such as identifying the distinctions between dietary supplement claims and drug claims, or between cosmetic claims and medical product claims. We also assist clients with issues involving multiple regulatory agencies, such as the interplay between FDA and the FTC in regulating advertising, the control of narcotics and other substances by FDA and the DEA, and the food safety system overseen by the U.S. Department of Agriculture and FDA.