FDA and regulatory law

As consumer interest in health, wellness and longevity has grown, so has investment in and development of truly innovative drugs, medical devices, foods, supplements and cosmetics. From functional foods and beverages to clean beauty, life-saving drugs and devices, and the emergence of CBD and hemp-based products, the last decade has seen an explosion in new and inventive products, processes and technologies. Naturally, state and federal regulatory oversight in these sectors has also expanded. Don’t let FDA and other regulatory issues be a road block to bringing your product to market and getting it in the hands of eager consumers.

McDonald Hopkins has significant experience representing clients of all sizes in FDA-regulated industries throughout the entire product and business lifecycle. Our attorneys provide strategic advice for clients from the inception to launch of their product, with a focus on gaining regulatory approvals, ensuring compliance and avoiding consumer and competitor challenges. We understand how a strong regulatory foundation can enhance the value of your products and business.

The services we often provide to our clients across FDA-regulated industries include:

  • Labeling, advertising and claim substantiation review for FDA, FPLA, and FTC compliance.
  • Medical device classification, marketing, and clearance.
  • FDA facility registration and product listing.
  • Good manufacturing practices (GMPs) and FDA Quality Systems Regulations.
  • Social media, sponsorship and influencer campaigns and agreements.
  • FDA and state regulatory inspections and warning letters.

Whatever the product category, McDonald Hopkins’ knowledge of the regulations and deep understanding of the challenges facing FDA-regulated industries will not only ensure you comply, but will help your business succeed.

Further, McDonald Hopkins understands the ultra-competitive landscape of FDA-regulated industries. Building, maintaining and protecting your business’s competitive advantage is our top priority. That’s why our attorneys are also well versed in state and federal Trademark, Unfair Competition and False Advertising laws and regularly helps our client leverage these laws to protect their brand reputation, industry goodwill, market share, and other assets.