Unlocking New Frontiers

Guiding through uncertainty

Gardner Law has the experience to advise clients on paths to obtain licenses and operate in this highly regulated environment. We provide support for clients in the research and development, manufacturing, and marketing of pharmaceutical and combination products that contain psychedelics, cannabis, cannabis-derived, and cannabis-related drug products.

We also advise clients in the food and beverage industry as it relates to hemp and traditional cannabis and psychedelics products, and work with state and FDA regulators to explore and resolve products issues. Whether you are in the business of growing, manufacturing, or selling cannabis or psychedelics products for medical or commercial adult use, we offer experience and valuable insight.

Representative Matters Include:

  • FDA regulatory strategy and submission support related to Investigation New Drug (IND), 505(b)(2) New Drug Application (NDA), Abbreviated New Drug Application (ANDA)
  • Strategy and preparation for FDA meetings and communications
  • Advised manufacturers on labeling and claims associated with cannabis and psychedelic products
  • Regulatory assessment and product approval pathways
  • Responded to warning letters related to health claims on cannabis and psychedelics products labels
  • State and local licensing and operating permits
  • Research and clinical study support, including drafting and negotiating Clinical Trial Agreements, subject recruitment practices
  • Regulatory assessment for product classification and regulatory pathway
  • Reviewing website and mobile apps, terms of use
  • Privacy and cybersecurity audits
  • Privacy and cybersecurity policies and procedures
  • Privacy and security incidents
  • Privacy officer and data protection officer services
  • Privacy training for organizations, including case coverage and complaint handling
  • FDA quality requirements, e.g., current Good Manufacturing Practices (cGMPs)
  • Recalls, corrections, and removals
  • Litigation and enforcement actions
  • Product liability strategy and counseling
  • Advertising and promotional review
  • Due diligence review for FDA-regulated companies