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: This article or section is in need of attention from an expert on the subject. ...

• 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. Oral medication Caffeine is the most widely used psychoactive substance in the world. ... A package insert or patient package insert (PPI) (in Europe, Patient Information Leaflet) is a document provided along with a prescription medication to provide additional information about that drug. ... Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs). ...

See also

• Regulation of therapeutic goods
• Federal Food, Drug, and Cosmetic Act
• Kefauver Harris Amendment
• Active ingredient
• Drug development
• Clinical trial
• Food and Drug Administration (FDA)
• European Medicines Agency (EMEA)
• Ministry of Health, Labour and Welfare (Japan)