Overview
FDA Regulatory Support
At Michael Best, our FDA Regulatory team helps you navigate the complex landscape of product regulation with confidence.
Our Approach: Your Partner in Policy and Progress
Strategic Planning & Road Mapping
We start with a comprehensive FDA regulatory assessment, reviewing your current compliance posture against applicable statutes, guidance documents, and enforcement trends. From there, we design a customized FDA compliance and advocacy roadmap with clear timelines, assigned responsibilities, and milestones—aligned with your business objectives and risk tolerance.
Execution & Implementation
Our team manages the full spectrum of FDA-related activities, including:
- Responding to FDA inspections and enforcement actions, including Form 483 and Warning Letter remediation. You’ll receive regular progress reports and dashboards to maintain transparency and control throughout the process.
Ongoing Monitoring & Continuous Improvement
We provide:
- Regulatory horizon scanning for FDA rulemaking, guidance updates, and enforcement priorities.
- Periodic compliance audits and refreshes to ensure sustained adherence.
- Post-matter debriefs and long-term compliance planning, embedding continuous improvement into your regulatory strategy.
"The Michael Best team is on top of regulatory developments."
"Through years of experience, the Michael Best team can bring long-standing relationships and familiarity with various regulators and their agencies."
"Michael Best is a fantastic firm. You get quality legal responses on time."
Experience
Our FDA Regulatory Experience
- We have experience in advanced manufacturing compliance issues such as FDA’s Current Good Manufacturing Practices (CGMPs) and Hazard Analysis and Critical Control Point (HACCP) requirements. Our counsel includes helping clients develop recall strategies; handling import requirements and removal from import alerts; drafting labeling, including “Nutrition Facts” and “Supplement Facts” panels; advising on advertising claims, including permitted structure/function claims; and helping clients understand and comply with evolving regulations under the Food Safety Modernization Act.
Michael Best has a long, deep history with the agricultural industry, which extends into federal regulatory issues. We advise clients on all aspects of compliance with FDA’s regulation of raw agricultural products and farm-produced foods (such as ciders and juices); handle matters involving the regulation of veterinary drugs and animal feed, including enforcement matters; and advise on regulation by the U.S. Department of Agriculture, such as the Federal Seed Act and labeling requirements for rBST.
