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:
“If an addict who has been completely cured starts smoking again he no longer experiences the discomfort of his first addiction. There exists, therefore, outside alkaloids and habit, a sense for opium, an intangible habit which lives on, despite the recasting of the organism.... The dead drug leaves a ghost behind. At certain hours it haunts the house.”
—Jean Cocteau (1889–1963)
“By an application of the theory of relativity to the taste of readers, to-day in Germany I am called a German man of science, and in England I am represented as a Swiss Jew. If I come to be regarded as a bête noire the descriptions will be reversed, and I shall become a Swiss Jew for the Germans and a German man of science for the English!”
—Albert Einstein (1879–1955)