New Drug Application (NDA)

For several decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). The NDA application 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 data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND), as was previously addressed, become part of the NDA.

Goals of the NDA

The goals of the NDA, according to the FDA, are to provide enough substantial evidence to permit FDA reviewers to reach the following key decisions:

• Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
• Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.
• Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

Pertinent Documentation

The documentation required in an NDA is intended to tell the drug's whole story, including the history and results of the clinical tests, the composition of the drug and drug product, the results of the preclinical studies, the drug’s ADME profile, and the methods by which the drug is manufactured, processed and packaged. The following resources provide summaries on NDA content, format, and classification, plus the NDA review process

• New Drug Application Process FDA CDER. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm
• For a brief history of U.S. drug law, please see http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm provides an understanding of how CDER works to assure that safe and effective drugs are available to the American people.
• Human Drug Current Good Manufacturing Practice Notes. http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm095412.htm

NDA Review Process

The following graphic provides insight into the NDA review process. Note that at the cited source, each step in the process is hyperlinked to additional details.

Research by Theresa Pipher