The Impact of Generic Drug User Fee Act on Generic Drug Export from India
Keywords: Generic Drug User Fee Act, Generic drugs, United States Food and Drug Administration (USFDA), Abbreviated new drug application.
AbstractGeneric drugs are drugs that have a similar active ingredient, dosage type, strength, and route of administration as a brand name medication. India is the hub of generic drugs and exports to various countries. The regulations for generics have been evolving through the years for better control of the price and quality of generic drugs. In this study, we have formulated a questionnaire consisting of questions on review time, communication with authority, the quality of products, and future expectations of the industry. Most people agreed that there had been a change since the introduction of generic drug user fee act (GDUFA). It has helped in reducing the review time of backlog applications, quick review for new applications, and raised certain expectations from the industry for the future of GDUFA. Communication has also improved between the industry and the food and drug administration (FDA), which has helped the applicant better understand the expectation of the authority.
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