ABSTRACT

In order to develop and market a novel drug in the U.S must be cognizant of this application of the Food Drug and Administration (FDA) known as the New Drug Application (NDA). Centre for Drug Evaluation and Research (CDER) is the department in the FDA that regulates the approval and review of safe and effective drugs for the public use. In general, NDA is applicable for new drugs which are not approved earlier and ANDA is for generic drugs. NDA is further divided into two types namely., 505(b)(1) and 505(b)(2) applications. NDA 505 (b)(1) is submitted by the sponsor for drugs that are novel and are to get approval for marketing and patient use. Whereas 505 (b)(2) is another FDA regulatory pathway submitted either by sponsor or applicant for approving a new drug that contains the active ingredient(s) which is/are already approved by FDA. Therefore, choosing an appropriate regulatory pathway is important. Hence, this article serves as a concise and quick guide for the applicant to determine the appropriate regulatory pathway, requirements for obtaining approval from FDA and a clear difference between these two regulatory pathways. Keywords: FDA, New Drug Application (NDA), Investigational New Drug (IND), Common Technical Document (CTD), 505(b)(1) pathway, 505(b)(2) pathway, Reference Listed Drug (RLD)
Publication date: 01/02/2023

https://ijbpas.com/pdf/2023/February/MS_IJBPAS_2023_6835.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.2.6835