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