FDA

Cracking Down on Overdose Deaths

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

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

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

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?

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?

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

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?

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 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

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

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

The Challenges of Regulating Brain-Machine Interfaces

Scholar highlights the fragmented regulatory environment governing advanced neurological technology.