The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:
- Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks?
- Is the drug’s proposed labeling (package insert) appropriate, and what should it contain?
- Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?
Read more about New Drug Application: Before Trials, Clinical Trials, The Actual Application, Requirements For Similar Products
Famous quotes containing the words drug and/or application:
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—Sophocles (497–406/5 B.C.)
“We will not be imposed upon by this vast application of forces. We believe that most things will have to be accomplished still by the application called Industry. We are rather pleased, after all, to consider the small private, but both constant and accumulated, force which stands behind every spade in the field. This it is that makes the valleys shine, and the deserts really bloom.”
—Henry David Thoreau (1817–1862)