Filing an Abbreviated New Drug Application (ANDA) with the FDA is a crucial step for generic pharmaceutical companies aiming to bring their products to market. However, the intricate regulatory landscape surrounding ANDA submissions can present significant challenges for these firms. One notable obstacle in this process is the FDA's Refuse to Receive (RTR) determination, which occurs when an ANDA fails to meet the minimum content requirements for review. This whitepaper delves into the various factors that may lead to the RTR spanning Fiscal Years 2013 to 2015. Moreover, this paper provides a thorough exploration of the distinction between major and minor deficiencies in ANDA submissions. In conclusion, the whitepaper underscores the critical importance for pharmaceutical companies to approach ANDA submissions with meticulous attention to detail and strict adherence to regulatory guidelines. It emphasizes the invaluable role of partnering with experienced consultants, such as Freyr, who can provide expert guidance and support throughout the regulatory process, ultimately ensuring a smoother path to successful ANDA submissions and market approval.
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