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.
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.
Reforming Health Care for Patients in Prison
Scholars discuss the lack of uniform standards for health care provided behind bars.
My Body, Whose Choice?
States should require doctors to seek informed consent before performing pelvic exams on anesthetized women.
Proposed Rule Seeks to Promote Value-Based Health Care
Federal regulators seek to expand safe harbors for provider care coordination arrangements.
How FDA Drug Review Contributed to the Opioid Epidemic
Scholars argue that FDA should use larger health data sets in its approval process for high-risk drugs.
Proposed Rule Aims to Make Drug Pricing More Transparent
A proposed requirement to display drug list prices in advertisements draws controversy.
Regulatory Collaboration Is Key to Public Health Success
Federal health agencies should work together to address public health problems.
Invoking a Right to Try in Regenerative Medicine
Scholars caution against using the Right to Try Act to skirt regulation for regenerative therapies.
FDA Reform Needs to Look More Like Tax Reform
U.S. regulators should model the medical device classification process on recent tax reform.