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Summary of New Drug Application

The Food and Drug Administration's (FDA) New Drug Application (NDA) is that the vehicle within the us through which drug sponsors formally propose that the FDA approve a replacement pharmaceutical purchasable and marketing.[1][2] Some 30% or less of initial drug candidates proceed through the whole multi-year process of drug development, concluding with an approved NDA, if successful

The goals of the NDA are to supply enough information to allow FDA reviewers to ascertain the whole history of the candidate drug. Among facts needed for the applying are :-
  • Patent and manufacturing information
  • Drug safety and specific effectiveness for its proposed use(s) when used as directed
  • Reports on the planning, compliance, and conclusions of completed clinical trials by the Institutional Review Board
  • Drug susceptibility to abuse
  • Proposed labeling (package insert) and directions to be used