The Role of the New Drug Application in FDA Approval


FDA pic

The founder and chairman of Cambridge Therapeutics, John Klein draws on more than two decades of experience as a senior executive with companies such as Zenith Laboratories, Ivax, and NovaDel Pharma. During his career, Cambridge Therapeutics founder John Klein has gained a deep understanding of the U.S. Food and Drug Administration’s (FDA) approval process.

Before applying for FDA approval to market a new drug, sponsors must file a New Drug Application (NDA), in which they are required to detail data and analyses regarding the drug’s manufacturing process, pharmacology, dosage, and toxicology, as well as any human and animal studies. Upon the submission of an NDA, the FDA can take as long as 60 days to decide if it is going to file it for further review or reject it on the basis that it requires additional information.

If filed for review, the NDA is then evaluated by the FDA’s Center for Drug Evaluation and Research (CDER), which can take up to 6 months to act on priority drugs and 10 months for all other drugs. The CDER can then either approve or reject the drug, or issue an approvable letter regarding the drug which states minor deficiencies that need to be corrected before ultimate approval. The NDA process has served as the basis for regulating new drugs in the United States since 1938.

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