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A process in the US where drug manufactures submit an application to the Food and Drug Administration (FDA) to gain a licence to market a new drug. This is done after clinical trials and aim to make sure the FDA has enough information to make a decision about the safety and efficacy of a drug.
See also:
Food And Drug Administration (FDA)
Pharmaceutical Researchers and Manufacturers of America (PhRMA)
License (product)
Clinical trial
Eligibility criteria, Clinical trial, Indication, Brief summary, Cohort, Product pipeline, Safety assessment of marketed medicines studies (SAMM), Empirical, Phase IV trials, Recruitment status, Clinical, Dose-ranging trial, Pre-clinical trials, Field experiments, Peer review,
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