Barriers and Challenges with the regulatory filing of generic medication in the United States.
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Abstract
Generic medications serve as cost-effective alternatives to branded drugs, offering the same quality, effectiveness, and safety. They have a well-established track record for safety and efficacy, making them crucial in expanding global access to affordable healthcare. However, stringent standards set by the US Food and Drug Administration (USFDA) can pose challenges for generic drug approval, causing delays in the registration process. The USFDA has one of the most rigorous regulatory authorities globally, and the application submitted for generic drug registration is called an Abbreviated New Drug Application (ANDA). The USFDA's primary responsibility is to ensure that the drug's development, production, and testing adhere to stringent regulations while maintaining detailed records.
To streamline the registration process, the International Conference on Harmonisation (ICH) has created a consistent framework for submitting applications, helping generic drug manufacturers meet the requirements for market approval in the US.
This study aims to identify the regulatory challenges associated with generic drug approval in the United States. By extensively analyzing data from regulatory websites, government sources, and relevant literature surveys, a comprehensive understanding of the generic medicine approval and registration process in the country has been established. The examination of various criteria for generic drug clearance in the US has revealed that the FDA's regulatory standards are highly effective and well-defined, ensuring the safety and efficacy of these cost-effective alternatives. However, it is crucial for manufacturers to meet these rigorous standards to facilitate the availability of generic medications and enhance global access to affordable healthcare options
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