Cracking Down on Overdose Deaths
FDA approves first over-the-counter treatment to combat the opioid overdose epidemic.
Patent Law Could Also Limit Mifepristone Access
Existing patents deter the marketing of more affordable generic drugs that could be used off-label for abortions.
The Growth in Business Support for Regulation
Businesses in the United States are increasingly supporting regulation and regulators against judicial decisions curtailing agency authority.
FDA’s Role in Access to Reproductive Health Care
Recent abortion pill litigation underscores the significance of calls to make birth control pills available over the counter.
Sugar, Spice, Are Additives Nice?
Scholar argues that loopholes in U.S. food regulation put consumers at risk.
Drug Safety, or Overregulation of Reproductive Health?
Scholar calls for FDA to remove stringent restrictions on medication abortion.
FDA, Not a Federal Judge, Should Decide on Abortion Drugs
Anti-abortion advocates take aim at FDA approval and regulation of the abortion drug mifepristone, threatening access nationwide.
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.