FDA’s Elsa at Eleven Months: AI-Powered Operations and One-Day Inspections Signal a New Oversight Paradigm
Recent United States Food and Drug Administration (FDA) announcements continue to highlight the agency’s increasing development and use of artificial intelligence. Earlier this month, FDA announced the launch of the latest version of Elsa – the internal AI solution it first announced last June. That same day, speaking at the Food and Drug Law Institute (FDLI) annual conference, the FDA Commissioner at the time, Dr. Martin Makary, announced a new pilot program for “one-day inspections” driven by AI-backed risk analysis for low-risk facilities. Taken together, and against the backdrop of Elsa’s launch less than a year ago, these developments show a continued push from FDA to leverage AI to expedite its operations, including in the enforcement space – a push that could have direct consequences for regulated entities across FDA product categories.
Key Steps Toward Using Artificial Intelligence in Pharmacovigilance – Sidley Insights on the Recent CIOMS Draft Report
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on how life sciences companies can take steps to implement key concepts from the Draft Report.
UK Life Sciences Sector Boosted By Raft Of New Policy Measures
A new policy document from the U.K. Government makes the life sciences sector a major focus for changes aimed at facilitating industrial growth. Marie Manley and Dr. Kwabena Tenkorang explain the relevant proposed changes, including reforms to speed up clinical trials, regulatory reforms, the introduction of low-friction procurement and the creation of a Health Data Research Service.
2025 Boston Life Sciences Roundtable
The 5th Annual Boston Life Sciences Roundtable, “Navigating New Frontiers,” brought together legal experts, industry leaders, and innovators for an afternoon of thought-provoking discussion, strategic networking, and forward-looking perspectives on the latest trends and hot topics shaping the industry. Discussions ranged from recent changes at the FDA to strategies on how to de-risk supply chains from recently imposed tariffs to new AI technologies and pathways for products, and creative approaches to funding sources and deal structures amid ongoing regulatory and geopolitical uncertainty, writes Mia Harris.
The Union of AI and Drug Discovery and Development Requires New Thinking for Structuring and Negotiating Strategic Transactions, and a Rigorous Analysis of Applicable Regulatory Considerations
The use of artificial intelligence and machine learning (AI/ML) in drug discovery and development is well established and here to stay. With AI tools developing the potential to impact virtually every stage of the life sciences product life cycle, the FDA continues to refine its framework for the use of AI to support regulatory decision-making. On April 7, the FDA ended its consultation period on two draft guidance documents, one containing recommendations on the use of AI to support FDA regulatory decision-making and another providing a “comprehensive approach” to the management of risk throughout the total product life cycle of AI-enabled devices. We also saw, in January of this year, the U.S. administration issue the Executive Order Removing Barriers to American Leadership in Artificial Intelligence. These developments, and potential developments, need to be carefully taken into account by life sciences companies that are considering transacting with an AI/ML tool provider.
How Life Sciences Companies Can Respond To DOJ’s Focus on Clinical Trial Fraud
For the past two years, clinical trial fraud has been a key enforcement area for the U.S. Department of Justice’s (DOJ) Consumer Protection Branch (CPB). David Ludlow and Julea Lipiz set out considerations for life sciences companies to help mitigate scrutiny of their trial results and related products.
Risks and Benefits of Generative AI for Pharma Supply Chain Management
As the life sciences sector grapples with complex challenges around sustainability and Environmental and Social Governance (ESG) compliance, Generative AI (GenAI) is emerging as a potentially powerful tool for enhancing efficiency and sustainability. Michele Tagliaferri, Eva von Mühlenen, and Anna-Shari Melin explain. (more…)
European Regulator Clarifies Guidance on the Use of AI in the Medicinal Product Lifecycle
The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.
How to Secure Investment as a Healthcare AI Innovator
For both small startups and R&D departments within larger companies, making investment funds work for an AI-based product is not just about securing initial funding but about making sure the investor understands the challenges of the healthcare sector. Chad Ehrenkranz talks to physician-executive and startup advisor Rick Abramson, MD, about the challenges.
Investor Attitudes to Healthcare AI Technologies
Investors are eyeing up the opportunities to invest in healthcare AI as it pushes the healthcare industry into new and exciting territory. R&D is currently focused on genomic sequencing, mapping, understanding populations and the treatment of rare diseases and hereditary cancer. AI applications are fundamentally altering how such R&D is conducted, as well as changing healthcare services to improve patient experience and outcomes. The advent of AI has dramatically altered the cost of capital, with private equity firms prepared to invest substantial sums into early adopters. These evolving opportunities raise important questions.