Home > 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.
- Jenis Kata: noun
- Industri / Domain: Perawatan kesehatan
- Kategori: Pencegahan & pengobatan AIDS
- Company: National Library of Medicine
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- Joseph Floyd
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