Newsletter - April 13, 2023
FDA Finalizes Risk-Based Monitoring Guidance with Practical Advice
The final FDA guidance on risk-based monitoring (RBM) for clinical trials released this week expands on the advice given in the draft guidance from almost 10 years ago with a goal to reduce overall in-person site monitoring visits and increase reliance on centralized remote monitoring...Read More
Digital Health Company’s Bankruptcy Highlights the Challenges of DM Products
The bankruptcy of Pear Therapeutics serves as a cautionary tale for the digital medicine industry. The Boston-based startup had raised over $200 million in funding, developed digital therapeutics for the treatment of substance use disorder and other mental health conditions, and got them through FDA approval...Read More
FDA Finalizes Risk-Based Monitoring Guidance with Practical Advice
The final FDA guidance on risk-based monitoring (RBM) for clinical trials released this week expands on the advice given in the draft guidance from almost 10 years ago with a goal to reduce overall in-person site monitoring visits and increase reliance on centralized remote monitoring...Read More
Digital Health Company’s Bankruptcy Highlights the Challenges of DM Products
The bankruptcy of Pear Therapeutics serves as a cautionary tale for the digital medicine industry. The Boston-based startup had raised over $200 million in funding, developed digital therapeutics for the treatment of substance use disorder and other mental health conditions, and got them through FDA approval...Read More
