首页 > Term: new drug application (NDA)
new drug application (NDA)
A drug sponsor's request to the Food and Drug Administration (FDA) for approval to sell and market a new drug in the United States. A new drug application (NDA) includes enough information for the FDA to determine whether the new drug is safe and effective; whether the drug’s benefits outweigh its risks; whether the proposed drug label (package insert) is appropriate; and whether the drug manufacturing standards are adequate.
- 词性: noun
- 行业/领域: 卫生保健
- 类别 AIDS 的预防和治疗
- Company: National Library of Medicine
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创建者
- Joseph Floyd
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