Artificial intelligence (AI) and machine learning (ML) have opened the door to revolutionary changes in the life sciences industry. AI is having a transformative impact on the ways in which the Food and Drug Administration (FDA) and FDA-regulated entities approach the development, manufacturing, use, and oversight of medical products.
How We Add Value
Our lawyers draw on their vast experience working with FDA and unparalleled industry know-how to help guide clients through the shifting AI regulatory landscape. Sidley’s Food, Drug and Medical Device (FDMD) Regulatory Team has experience advising clients on the uses of AI throughout a product’s life cycle, including how products are developed, manufactured, and monitored. With its global platform and cross-disciplinary approach, Sidley is well positioned to help clients embrace opportunities, navigate uncertainties, prepare for, and share their thought leadership on emerging regulatory frameworks.
Representative Matters
We provide a range of services related to FDA’s approach to AI, including:
- Counseling biopharmaceutical companies on potential FDA regulation of software functions and AI technologies used in clinical trials
- Advising consumer health companies and systems on specific carve-outs in FDA law for certain software functions using AI technologies to support physicians
- Counseling clients on informed consent considerations when AI is used in a clinical setting
- Advising life sciences companies on AI governance policies, including the use of generative AI/large language models (LLMs)
- Conducting multi-jurisdictional reviews of AI regulatory developments for global multinationals
- Advising consumer health entities on the use of images generated with AI in marketing materials
- Guiding pharmaceutical and medical device clients through FDA regulatory approval, clearance, or authorization and reimbursement considerations for products using AI
- Advising on the uses of AI in pharmacovigilance
- Counseling clients on the deployment and implementation of AI to strengthen manufacturing compliance and supply chain efficiency
- Supporting clients on AI-related regulatory issues for mergers and acquisitions, asset purchase agreements, licensing, lending, securities offerings, and other transactional matters
- Advising on the use and role of third parties (e.g., voluntary standards, certifications, and use of foundation models)
Sidley Thought Leadership
- FDA Regulation of AI in Life Sciences
- Sidley AI Monitor
- GoodLifeSci: Perspectives for the Life Sciences Community