ISSN: 2642-6315
Authors: Sambathkumar R*
Generic drugs stand as a beacon of hope within the realm of medicine, offering a pragmatic and wallet-friendly solution for patients seeking essential treatments. They open the doors to the same therapeutic benefits as their brand-name counterparts, all without imposing exorbitant financial burdens. This revolutionary journey begins with the Abbreviated New Drug Application (ANDA), a pivotal gateway into the stringent regulatory landscape overseen by the U.S. Food and Drug Administration (FDA). Unlike the labyrinthine process faced by novel drugs, generics enjoy a streamlined path to approval, showcasing their equivalence to the original through meticulous validation of identical active ingredients and efficacy. This efficient route not only saves precious time but also preserves valuable financial resources, sidestepping the need for redundant testing mandated for new drugs. With the coveted FDA seal of approval, these generic marvels burst onto the market, offering patients a cost-effective alternative without any compromise on quality or effectiveness. In essence, generic drugs emerge as beacons of accessibility, ensuring that essential treatments reach the masses while steadfastly upholding the highest standards of safety and efficacy. They represent not just a practical solution, but a transformative force in democratizing healthcare access for all.
Keywords: Generic drugs; Abbreviated New Drug Application (ANDA); United States Food and Drug Administration; Regulatory landscape; expedited process; Cost-effective; Quality and Efficacy; Food and Drug Administration (FDA)
