Is Your Phone a Medical Device?
Scholar argues that Congress and FDA should treat risky clinical artificial intelligence tools as medical devices.
FDA Advances Program for Real-World Evidence
FDA’s approach to evidence-based decision-making may not be addressed to the right people.
Underrepresented, Overmedicated, and Misdiagnosed
Experts contend that FDA clinical trials fail to ensure adequate consideration of women’s health needs.
Expanding FDA Incentives to Boost Diversity in Clinical Trials
Exploring FDA’s toolkit for encouraging study sponsors to meet diversity goals.
The Challenges of Regulating Brain-Machine Interfaces
Scholar highlights the fragmented regulatory environment governing advanced neurological technology.
Marketing Formerly Dangerous Drugs
Two scholars find that the removal of FDA health warnings prompts an increase in drug marketing.
The AI Health Care Dilemma
Scholars explore regulatory approaches to artificial intelligence in the health care sector.
How Factory Farming Could Cause the Next COVID-19
The CDC should recommend agricultural reforms to reduce pandemic risks caused by factory farms.
Toxic Metals in Baby Food Remain Unregulated
Despite delayed government action, manufacturers can do more to reduce toxic metals in baby food.
Telehealth Abortion Care
Scholars consider how the authorization of telehealth can expand access to medication abortion.
Are Food Regulators Stepping up to the Plate?
In this week’s Saturday Seminar, we collect scholarship discussing quality and safety issues within U.S. food regulation.
Using Insurance to Regulate Food Safety
Insurance underwriters can help farmers manage the risk of microbial contamination in their fields.