• Scholars are debating the ethical implications and potential improvements to the FDA's accelerated approval pathway for drugs targeting serious conditions.
• Concerns persist regarding the use of surrogate endpoints and the need for rigorous post-approval trials to confirm clinical benefits.
• Experts propose various reforms, including independent review bodies and stricter post-market surveillance, to enhance transparency and accountability.
• International comparisons reveal differing approaches to drug approval, highlighting the need for harmonized standards and greater transparency in post-marketing studies.