The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
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In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more
Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more
U.S. antitrust enforcers launched a flurry of initiatives in the first half of 2024 to identify and prevent antitrust and other violations in life sciences and health care. Among these are two cross-agency Requests for...more
This report series examines quarterly trends in life sciences venture investment. Key findings for Q1 2024 include: • Life sciences VC deal value in Q1 totaled $7.8 billion, which represents a 22.1% increase in value from Q4...more
The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the United States (U.S.), the United Kingdom (UK)...more
In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more