The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality.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The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.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
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
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
COVID-19 has had far-reaching social, economic and regulatory impacts. Nearly all companies (private and public, large and small) have had reason to more frequently convene their boards of directors to review and monitor...more
6/22/2020
/ Board of Directors ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Corporate Governance ,
Derivative Suit ,
Food and Drug Administration (FDA) ,
Internal Controls ,
Life Sciences ,
Oversight Duties ,
Pharmaceutical Industry ,
Research and Development