InterviewSolution
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InterviewSolution
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What Is A New Drug Application? |
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Answer» The NDA is the vehicle through which drug SPONSORS formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug BECOME part of the NDA In SIMPLE words, “It is an application which is FILED with FDA to market a new Pharmaceutical for sale in USA” The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA” |
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