Publication Date: 2024/03/15
Abstract: There are distinct regulatory approval processes needed in the discovery and development of novel medications. Finding new pharmaceuticals requires extensive study in the fields of chemistry, production, control, pre-clinical science, and clinical trials. The next step is to submit an IND after new medications are identified. The primary goal of the IND application is to obtain approval for human subjects clinical trials (Phase 1, 2, and 3). The next step once clinical trials are finished is the New Drug Application (NDA). The primary goal of the NDA application process for the development of new drugs is obtaining approval to sell the medications on the open market. Once the patient has passed away, the sponsor should apply to the ANDA right away. Obtaining authorisation for the sale of the generic medication is the primary goal of the ANDA.ANDA state that Abbreviated New Drugs Approval that are used for the generic drug approval.
Keywords: Drugs Approval Process_INDA (Investigational New Drugs Application), NDA(New Drugs Application) and ANDA(Abbreviated New Drugs Application).
DOI: https://doi.org/10.38124/ijisrt/IJISRT24MAR495
PDF: https://ijirst.demo4.arinfotech.co/assets/upload/files/IJISRT24MAR495.pdf
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