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Healthcare Glossary
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New Drug Application (NDA)
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
Related terms
Fair balance, Toxicity, Efficacy, Prevention trials, Committee for Medicinal Products for Human Use (CHMP), Cohort, Peer review, Indication, Phase III trials, Side-effects, United States adopted name (USAN), British National Formulary (BNF), Safety assessment of marketed medicines studies (SAMM), Newspaper Licensing Agency (NLA), Arm,
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Syneos Health®
Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and...
