Drug Trials

Restoring FDA’s Premarket Review Powers

Restoring FDA’s Premarket Review Powers

Scholar proposes reforms to address deficiencies in FDA’s premarket review powers.

Ethical Considerations for FDA Accelerated Approval

Ethical Considerations for FDA Accelerated Approval

Scholars debate ways to improve FDA’s accelerated approval mechanism.

Underrepresented, Overmedicated, and Misdiagnosed

Underrepresented, Overmedicated, and Misdiagnosed

Experts contend that FDA clinical trials fail to ensure adequate consideration of women’s health needs.