The NDA process is the route taken by manufacturers to request FDA’s approval of a new drug for sale and marketing in the U.S. as specified in the Federal Food, Drug, and Cosmetic Act of 1938.
The goals of the OTC NDA process are to provide enough information to permit an FDA reviewer to determine: 1) whether the drug is safe and effective in its current state and whether the benefits of the drug outweigh the risks; 2) whether the drug’s proposed labeling is adequate; and 3) whether the methods used in manufacturing are adequate to preserve the drug’s identity, strength, quality, and purity.
After an NDA application is received by FDA, it must first be deemed worthy of a formal review. The information is then forwarded on to a team of reviewers such as physicians, chemists, pharmacokineticist, and statisticians who examine the data submitted for accurateness. FDA also may elect to call on its advisory committees for additional review and recommendations.
During the review of an NDA, CDER usually also communicates with the NDA applicant, or the sponsor, regarding a variety of procedural issues. In some cases, the applicant may submit new data to the NDA, which may result in a time extension for the application.
Once FDA determines that the application information is complete and acceptable (including labeling information and manufacturing inspections), the reviewers and their supervisors reach an approval recommendation. Once the division director signs an approval action letter, the product can be legally marketed starting that day in the United States.
