When clinical testing has been completed and analyzed, final manufacturing processes and procedures are in place, and the company has ready other required information, it must submit a New Drug Application (NDA) to the FDA. No action can be taken to market any therapeutic drug product in the U.S. until the FDA has approved an NDA.
The data in the NDA must establish that the drug is safe for use under the proposed labeling conditions and is effective for its proposed use(s). Substantial evidence is defined by statute and FDA regulation to mean evidence consisting of adequate and well-controlled investigations, including clinical investigations by experts qualified by scientific training and experience, to evaluate the effectiveness of the drug involved.
The NDA must contain data-obtained outlines from the clinical trials of the drug, as well as a description and analysis of the drug’s pharmacokinetics. It must also include a description and analysis of any other data relevant to the safety and effectiveness of the drug product obtained from any source, foreign or domestic.
The NDA also includes an integrated summary of all available information about the safety of the drug product, including potential adverse effects and clinically significant potential adverse reactions with other related drugs.
A section of the NDA discusses the statistical, controlled clinical study and the documentation and supporting statistical analysis used in evaluating the controlled clinical studies. Another section describes bioavailability of the drug, including the data concerning the action of a drug in the human body over a period of time and the extent of drug absorption in the human body or information supporting a waiver of the submission of such data.
The NDA must describe the composition, manufacture, and specification of the drug substance, including a full description of the drug substance, its physical and chemical characteristics, and its stability; the process controls used during manufacture and packaging; and such specifications and analytical methods as are necessary to assure the identity, strength, quality, and purity of the drug substance, as well as the availability of the drug products made from the substance.
NDAs contain lists of all components used in the manufacture of the drug product and a statement of the specifications and analytical methods for each component.