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| FDA's Drug Review Process: Continued | |||
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| 분류 | New Drug | 조회 | 2311 |
| 발행년도 | 2014 | 등록일 | 2015-07-27 |
| 출처 | FDA (바로가기) | ||
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Drug Review Steps Simplified
-Preclinical (animal) testing.
-An investigational new drug application (IND) outlines what the sponsor of a new drug -proposes for human testing in clinical trials.
-Phase 1 studies (typically involve 20 to 80 people).
-Phase 2 studies (typically involve a few dozen to about 300 people).
-Phase 3 studies (typically involve several hundred to about 3,000 people).
-The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
-Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
-After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
-If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
-The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
-The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
-FDA reviewers will approve the application or issue a complete response letter.
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 이전글 |
항체를 이용한 HIV치료법 |
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 다음글 |
Guidance for Clinical Investigators, Sponsors, and IRBs Investigational New Drug Applications (INDs) |
