ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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New Drug Application (NDA)

Under the Food, Drug, and Cosmetic Act of 1938, the NDA was submitted to the FDA enumerating the uses of the drug and providing evidence of its safety. If the FDA found no reason to object, the NDA was automatically approved within sixty days. But since 1962 the FDA evaluates proof of efficacy as well as proof of safety, and the company must wait for FDA approval no matter how long that takes. On average, the NDA review process lasts for two years (as of the mid-1990s, some evidence suggests times have shortened). The NDA review is handled by the FDA's Center for Drug Evaluation and Research (CDER). Once the CDER deems the NDA fileable, the medical, biopharmaceutical, pharmacology, statistical, chemistry, and microbiology departments of the CDER review it. The length of an NDA application can reach one hundred thousand pages of material. If the departments pass the NDA, an advisory committee meets. If the advisory committee is satisfied with all of the findings, a labeling review takes place. Once the labeling review is complete, the NDA is approved, and the drug is ready to be marketed.

Publication Source: Committees on Human Research

See also: IND (Investigational New Drug) Application

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