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New Drug Application
abbr., med. NDA (gconnell)
New Drug Applications
physiol., abbr. NDA
New Drug Application NDA
med. A drug sponsor's request to the Food and Drug Administration FDA for approval to sell and market a new drug in the United States. A new drug application NDA includes enough information for the FDA to determine whether the new drug is safe and effective; whether the drug's benefits outweigh its risks; whether the proposed drug label package insert is appropriate; and whether the drug manufacturing standards are adequate. see also food and drug administration
New Drug Application: 2 phrases in 1 subject
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