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FDA Regulatory

Practices

FDA Regulatory

We provide strategic counseling regarding FDA-regulated products, including foods, drugs, medical devices, cosmetics, veterinary products and tobacco products. Given FDA’s immense size and its extensive jurisdiction, regulated entities often have questions about navigating the agency. Our lawyers have extensive knowledge needed to effectively work with the FDA, share best practices, and assist clients in navigating through a wide range of agency matters, including imports and exports, product approvals, and good manufacturing practices, among others.

We also have experience with responding to compliance and enforcement actions and bringing litigation against the agency. Our focus is to provide insight and practical advice to help clients achieve their goals while adhering to applicable laws and regulations.

Following are some illustrative examples of our experience:

  • Helping companies coordinate with FDA during the entry process to avoid import refusals and address shipment holds.
  • Advising companies on premarket authorization requirements for FDA-regulated products, including drugs, medical devices, and tobacco products.
  • Helping companies respond to FDA Form 483s (inspectional observations) and Warning Letters.
  • Bringing a successful challenge to FDA’s denial of a premarket tobacco product application. Wages & White Lion Investments, LLC v. FDA, 90 F.4th 357 (5th Cir. 2024) (en banc).