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| регистрационное досье (The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks? Is the drug’s proposed labeling (package insert) appropriate, and what should it contain? Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? WK Alexander Demidov) | |||
| заявка нового лекарства (заявление в федеральное агентство за разрешением на продажу нового лекарства) | |||
| досье нового лекарственного препарата (kunya7) | |||
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| Применение новых лекарственных средств (FDA, положение Департамента по контролю за качеством пищевых продуктов, лекарственных и косметических средств); Заявка на регистрацию нового препарата (dr_denver) | |||
| заявка на регистрацию нового лекарственного средства (Conservator) | |||
| English thesaurus | |||
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| NDA (gconnell) | |||
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| 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. see also food and drug administration | |||
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| NDA | |||
| new drug application: 23 phrases in 8 subjects |
| Biotechnology | 3 |
| Clinical trial | 2 |
| General | 1 |
| Law | 3 |
| Medical | 6 |
| Pharmacology | 6 |
| Pharmacy and pharmacology | 1 |
| Veterinary medicine | 1 |