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newdrugapplication
new drug application
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The answer NEWDRUGAPPLICATION (new drug application) has 0 possible clue(s) in existing crosswords.
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The word NEWDRUGAPPLICATION (new drug application) is NOT valid in any word game. (Sorry, you cannot play NEWDRUGAPPLICATION (new drug application) in Scrabble, Words With Friends etc)
There are 18 letters in NEWDRUGAPPLICATION ( A1C3D2E1G2I1L1N1O1P3R1T1U1W4 )
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Definitions of new drug application in various dictionaries:
NEW DRUG APPLICATION - The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that t...
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New drug application description |
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The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are: * Patent and manufacturing information * Drug safety and specific effectiveness for its proposed use(s) when used as directed * Reports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review Board * Drug susceptibility to abuse * Proposed labeling (package insert) and directions for useExceptions to this process include voter driven initiatives for "medical" marijuana in certain states. |