New drug application
From Wikipedia, the free encyclopedia
The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following:
- Is the drug is safe and effective in its proposed use(s), and do the benefits of the drug outweigh the risks?
- Is the drug's proposed labeling (package insert) appropriate, and what should 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?
The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. Once approval of an NDA is obtained, the new drug can be legally marketed starting that day in the United States.
