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Abbreviated new drug application

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Md. Mizanur Rahman

Abbreviated new drug application

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Investigational new drug (IND): Investigational new drug (IND) deals with a new chemical entity, which will be tested for obtaining evidence of safety and effectiveness in accordance with the regulations. New drug application (NDA): New drug application (NDA) is a document submitted to the regulatory authorities for permission to market a new drug product in that country. Abbreviated New Drug Application (ANDA): Drug manufacturers must file an ANDA for approval to market a generic drug product. The generic manufacturer is not required to perform clinical efficacy studies or nonclinical toxicology studies for the ANDA.

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Abbreviated new drug application

  • 1. Investigational new drug (IND): Investigational new drug (IND) deals with a new chemical entity, which will be tested for obtaining evidence of safety and effectiveness in accordance with the regulations. New drug application (NDA): New drug application (NDA) is a document submitted to the regulatory authorities for permission to market a new drug product in that country. Abbreviated New Drug Application (ANDA): Drug manufacturers must file an ANDA for approval to market a generic drug product. The generic manufacturer is not required to perform clinical efficacy studies or nonclinical toxicology studies for the ANDA.