Arent Fox works with clients from the beginning of product development to evaluate the regulatory landscape and develop strategies for testing and approval of innovative consumer, medical, industrial, and agricultural products, including products improved through biotechnology. Genetically engineered seeds and plants often require clearance from several federal agencies.
- Negotiating with regulatory agencies such as Federal Drug Administration, Drug Enforcement Administration, Environmental Protection Administration, and US Department of Agriculture.
- Securing product approvals.
- Coordinating clinical studies, field tests, and environmental assessments.
- Reviewing product labeling and advertising and managing recalls and enforcement actions.
- Developing risk management strategies.
- Counseling clients on regulatory compliance issues, including export/import clearances, adverse incident and other reporting requirements, government inspections and audits, and protection of trade secrets and other proprietary information.