Capabilities / FDA Regulatory

FDA Regulatory

Providing the legal and regulatory experience with science-based knowledge needed to ensure science-based solutions.

The U.S. Food and Drug Administration (FDA) regulates more than $2.7 trillion worth of products that include food, drugs, medical devices, biologics, dietary supplements, tobacco, and radiation emitting electronic products. Collectively, these products account for nearly 20 cents out of every consumer dollar. Our dedicated team of professionals is committed to guiding client businesses through the rigorous landscape of FDA regulatory compliance. With proven success in the field, we understand the importance of staying ahead in a dynamic environment where regulations and science are ever evolving.

Effectively navigating the FDA’s regulations for these products requires a thorough understanding of a broad body of knowledge spanning a variety of disciplines including:

Drug stability
Manufacturing quality systems
Food-borne pathogen monitoring
Material biocompatibility
Tissue residues
Artificial intelligence and machine learning algorithms
Toxicology
Hazard analysis and critical control points production techniques
Pharmacopeial monographs
Validation study design

Often, navigating an issue requires understanding the science as much as understanding the law. At Husch Blackwell, our attorneys hold degrees in fields such as chemical engineering, biological sciences, and animal sciences. Our professionals have real-world experience in research laboratories developing cutting edge biotech, as auditors inspecting major U.S. and foreign medical technology manufacturers, and with trade groups developing technical policies on critical issues affecting food industries.

Whether bringing a new product to market or responding to FDA enforcement, our experienced team is here to help. We offer experienced guidance to navigate the complexities of regulatory requirements, ensuring a smooth and successful path to market for client products.

Our FDA regulatory counsel and FDA compliance legal guidance include:

Pre-market strategy and compliance

Product classification and risk assessment: Identification of appropriate regulatory pathways, including for drugs, medical devices, biologics, and dietary supplements
Regulatory submission and approval: Experienced preparation and support for INDs, NDAs, BLAs, 510(k) submissions, De Novo classifications, and PMA applications
Quality systems and good manufacturing practices (GMP): Assistance in implementing comprehensive quality systems that comply with FDA regulations

Post-market surveillance and reporting

Adverse event and recall management: Proactive strategies for post-market surveillance, addressing potential safety concerns, and managing voluntary or FDA-mandated recalls
Labeling, promotion, and advertising: Ensuring compliance with FDA requirements for product labeling and marketing materials
Compliance and enforcement actions: Representation for FDA inspections, warning letters, and enforcement actions, including negotiation and legal defense

FDA regulatory consulting and audits

Guidance on regulatory changes: Ongoing consultation to navigate through changes in FDA and state policies and regulations
Mock FDA audits and inspections: Preparation for FDA audits with simulated inspections and assistance in developing corrective action plans

Global regulatory strategy

International compliance: Support in aligning a product with global regulatory requirements, including the EU’s MDR and IVDR

Representative Experience

Handle complex food recall solutions for client including FDA communications, dispute with supplier that provided recalled product and claims/dispute with insurer.
Advise client in preventing or responding to FDA and FSIS inspection citations and enforcement actions such as 483s, warning letters, import detention and agency investigation, as well as provide real-time advice during facility inspections and recall situations.
Guide start-up energy drink company in formulation, FDA labeling, and substantiation of marketing claims for products.
Assist clients in developing lawful labels, claims and marketing programs for USDA and FDA-regulated products.
Develop FDA, AFFCO, state and Canadian compliant labels for international animal feed and pet food companies.
Represent food industry clients at hearings, briefings, and meeting with Congress, FDA, USDA, DHS, USEPA, DOL-OSHA and other administrative agencies.
Guided pet food company through recall of salmonella contaminated product and follow up with state and federal regulators on closing of recall.
Assist clients on formulation and labeling for new and innovative TTB and FDA regulated alcohol beverage products including wine, hard seltzers, beer, and whiskey brands.
Assist OTC drug and cosmetic manufacturer in developing corporate security plan, emergency response plan, and crisis management plan to assist with CTPAT compliance.
Counseled a foreign animal health manufacturer on the FDA and USDA compliance aspects impact potential acquisition of a U.S. animal health manufacturing facility.
Handle import holds of FDA regulated products.
Assist clients with registration and listing of FDA-regulated facilities and businesses.

Related areas of focus:

Chemistry & Biotech Clinical Research & Trials Digital Health Generic Drug / ANDA Litigation Licensing & Tech Transfer Life Sciences Patent Preparation & Prosecution Pharmaceutical Manufacturers Pharmacy Psychedelics & Emerging Therapies

Key Contacts

Seth A. Mailhot

Partner

Emily R. Lyons

Partner

View our entire team

“

The Husch Blackwell attorneys were fierce and tireless advocates for Virtus. In the face of aggressive actions by our competitors and FDA regulators, they developed and executed a legal plan that protected an important market for us. They have my gratitude and highest recommendation.

Tina Guilders, CEO, Virtus Pharmaceuticals