Envisioning the Dual Repercussions of FDA’s Accelerated Approval Pathway
Clinical trials are comprehensive research studies conducted to ensure that recently developed medical interventions, including novel drugs, surgical & other devices, and treatments/ therapies, are safe and effective for human use before commercialization. These trials provide evidence for regulatory bodies like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, UK’s Medicines and Healthcare Products Regulatory Agency, and China’s National Medical Products Administration (NMPA) to ensure that a specific medical intervention is safe for the public use, begets limited adverse effects, and meets quality standards. However, it takes 10 to 15 years or even more to complete all three clinical trial phases before reaching the licensing stage. Thus, FDA introduced accelerated or expedite approvals to pace up the approval of drugs that treat severe conditions and address unmet medical needs. Before proceeding with the pros and cons of the FDA’s expe...