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. However, it was unable to yield returns it projected … 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FDA guidance on risk-based monitoring (RBM) for clinical trials released this week expands on the advice given in the draft guidance from almost 10 years ago with a goal to reduce overall in-person site monitoring visits and increase reliance on centralized remote monitoring. Overall, this is not new information but confirmation of prevailing … Read more