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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
Medical
2
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