When a loved one with a rare condition or serious illness exhausts all treatment alternatives, what do their loved ones go through? It's possible that millions of families are currently experiencing this nightmare throughout the world. US FDA introduced an expanded access program (EAP) in 1987, which provides a compassionate pathway for individuals facing serious or life-threatening medical conditions, especially when standard treatments have been exhausted. There are various categories of EAPs, encompassing single patient Investigational New Drug (IND) Application, Intermediate-Size population IND, Treatment INDs, Emergency Use IND, and Parallel Track EAPs. Expanded access programs have a significant impact on drug development; their contributions to real-world data, improvement of safety profiles, optimization of dosage, and facilitation of prompt patient access to potential medicines are undeniable. A global perspective on EAPs emphasizes their role as beacons of hope in addressing healthcare disparities. The regulatory landscape governing EAPs is explored, focusing on the United States Food and Drug Administration (USFDA), the European Union, and India, with a spotlight on proposed amendments to the New Drugs and Clinical Trials Rules, 2019, in India, suggesting the establishment of a structured regulatory framework in the future. This may provide a pathway to address challenging health situations, offering hope, dignity, and the potential for improved outcomes in the nation.
Impact Factor
2022: 6.012
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