File uploads: We have fixed an issue which caused file uploads to fail. We apologise for the inconvenience it may have caused.

Published June 7, 2022 | Version v1
Journal article Open

A Review on New Drug Application (NDA) and General Consideration in Pharmaceutical Industry

  • 1. SRES's Sanjivani College of Pharmaceutical Education and Research, Kopargaon
  • 2. Department of Formulation & Development Scientist, Intelliscend NDDR Thane (W), Maharashtra, India 400604

Description

ABSTRACT

In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The components of any NDA are a function of the nature of the subject drug and the information available to the applicant at the time of submission. The form to use for either NDA or ANDA is Form FDA-356h, Application to Market a New Drug for Human Use or as an Antibiotic Drug for Human Use. The international regulatory authorities under consideration are WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM. To legally gather this data on safety and effectiveness in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA.

Keywords: Regulatory authority, ANDA, NDA, IND.

Files

AJPTR123009.pdf

Files (375.8 kB)

Name Size Download all
md5:8ef2aae2fbf912fc0e7574f986986902
375.8 kB Preview Download