Envisioning the Dual Repercussions of FDA’s Accelerated Approval Pathway
                     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 expedited program, let’s first 
understand  the full-fledged approval process set by various regulatory agencies to 
launch any novel medical  interventions in the market after comprehensive analysis.
 Pre-Approval: the regulatory agencies set specific guidelines around study 
design,  volunteer selection, monitoring procedures, informed consent, and 
data collection, which  pharmaceutical industries must adhere to when 
conducting clinical trials.
 Investigational New Drug (IND) Application: Drugmakers/ sponsors are 
obliged to  submit an IND application to the regulatory body before initiating a 
clinical trial. This  application comprises justification, proposed study design, 
safety data from pre-clinical  studies, and a feasible approach to monitor 
volunteers during the trial.
 Review Process: The regulatory agency thoroughly reviews the statistical 
data, data  quality, results of all phases of pre-clinical and clinical trials, and 
potential benefits & risks  associated with the particular intervention.
 Post-Approval: Even after granting approval for marketing and 
commercializing medical  interventions, the regulatory body continues to 
monitor the safety and efficacy of approved  products through post-marketing 
surveillance and requires periodic reporting of adverse  events.
Need for introducing USFDA Accelerated Approval Program
The US FDA’s Accelerated Approval Program (AAP) aims to expedite the development and  
enable faster access to new therapies that address an unmet need in treating severe
ailments. This program is mainly introduced to promote the treatment of chronic diseases,  
where the course of the condition is extended, and determining the clinical endpoint would 
 take considerable time. The primary objective behind introducing a priority review of
specific drugs for accelerated approval is to launch the drugs earlier in the market. To justify,  
in the case of chronic diseases like HIV and cancer, thoroughly understanding the effect of  
medications with precision can take a long time, which results in delayed drug approval.
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