Compliance with FDA requirements and guidance is critical at every stage of a regulated company's life cycle and throughout product development.
We provide comprehensive regulatory, compliance, and risk management guidance as FDA-regulated clients research, develop, market, and sell their products. Our clients range from startups to global industry leaders in pharmaceuticals, active pharmaceutical ingredients, biologics, orphan drugs and breakthrough therapies, human tissue-based products, medical devices (510(k), HDE, PMA, and other pathways), radiation-emitting products, over-the-counter drugs, cosmetics, and personal care products.
We work with clients at all stages of the development process. Our multidisciplinary team advises clients on regulatory compliance, litigation, and enforcement risk throughout the product lifecycle. We offer attorneys whose practices focus on corporate and securities, intellectual property, risk management and mitigation, government investigations and enforcement, as well as product liability and other complex litigation.
We counsel on liability issues raised by required safety submissions — such as Periodic Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, Annual Reports, and Development Safety Update Reports — and on client procedures for capturing, analyzing, and reporting adverse events. We advise on clinical trial issues arising out of protocols, clinical investigator brochures, informed consent documents, final study reports, IRB interactions, agreements with contract research organizations, and safety monitoring and reporting.
Our team also develops and implements response strategies when faced with critical challenges, such as advisory committee meetings, inspections, product recalls, warning letters, FDA safety alerts, "Dear Doctor" letters, clinical trial holds, Form 483 citations, REMS, FOIA requests, and regulatory enforcement action. We also offer access to our network of industry experts, including former FDA officials, GMP and quality compliance experts, and public relations firms.
Podcasts
06.25.24
The FDA's Response to AI Medical Innovation
Articles + Publications
05.28.24
Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context
Articles + Publications
05.23.24
FDA Issues Final Rule on Regulation of Laboratory Developed Tests
Articles + Publications
04.10.24
New FDA Guidance on AI and Medical Products
Speaking Engagements
03.06.24
Epiq's Mass & Class 2024 Summit, "Early Exchange of Information: What Works for Both Sides"
Regulatory Oversight
02.07.24
TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes