U.S. New Drug Application (NDA)

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2025-07-11 08:01:58 -

According to laws and regulations such as The Food, Drug and Cosmetic Act and Code of Federal Regulations Title 21, the new drug review process of the US Food and Drug Administration (FDA) includes two parts: IND application for new drug clinical trials and NDA application for new drug marketing. https://www.proregulations.com/u-s-new-drug-application-nda.html

U.S. New Drug Application (NDA) - Proregulations

Our company offers a range of new drug application (NDA) services for all parties, including sponsors who need to submit and navigate the final leg of the drug development process, to increase the likelihood that the NDA will be approved.

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