FDA Regulatory

Morrison & Foerster’s full-service FDA Regulatory Practice advises clients in the life sciences industry, helping them navigate complex regulatory, compliance, health care system, and marketplace issues. With a strategic and comprehensive life-cycle approach, our experienced lawyers counsel domestic and international clients, from pre-product launch to post-market representation. We counsel clients in the medical device, pharmaceutical, food and dietary supplement, biotechnology, healthcare technology, and cosmetic industries, ensuring that they are FDA compliant as well as optimally positioned for maximum coverage and reimbursement, entry into new global markets, and further research and development.

Our clients include:

  • emerging companies looking for regulatory pathway development and strategic alignment with critical business goals;
  • private equity firms and other investors requiring specialized diligence and transactional support in the highly regulated life science and healthcare industry;
  • companies needing regulatory counsel regarding product labeling, advertising, and promotion and development of strong compliance programs;
  • product developers requiring guidance on federal and state regulatory laws impacting product design, commercialization strategy, and product launch; 
  • life sciences sponsors seeking to engage effectively with the FDA through strong strategies and clear submissions;
  • academic medical centers and technology transfer groups seeking to maximize the value of their technology through strong regulatory strategies and actions; and
  • regulated businesses facing product recalls, government investigation, and litigation.

Consistent with MoFo's collaborative approach, we work seamlessly with other lawyers across the firm to meet our clients’ comprehensive needs regarding FDA regulations, compliance, enforcement, policy, and strategic counsel, as well as with our Consumer Products and Global Privacy + Data Security teams on HIPAA, connected health, and clinical trial compliance matters, among others. This integrative approach provides our clients with the highest quality counsel for developing cutting-edge solutions that ensure product compliance and maximal market potential.

Complete Product Life Cycle Counsel

  • FDA Communications Strategies
  • Pre-Market Product Development
  • Market Authorization Processes
  • FDA Submissions
  • Product Labeling, Advertising, and Promotion
  • Regulatory Compliance
  • Healthcare Provider Collaboration
  • Reimbursement
  • Import/Export
  • Policy Issues
  • Inspections
  • Fraud and Abuse Investigations
  • Enforcement and Recalls

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