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| Small Business Assistance: Frequently Asked Questions on Drug Development and Investigational New Drug Applications | |||
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| 분류 | Investigational New drug application | 조회 | 2434 |
| 발행년도 | 2015 | 등록일 | 2015-07-27 |
| 출처 | FDA (바로가기) | ||
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Investigational New Drug Process
•An Introduction
•Definitions
•Types of INDs
•Phases of an Investigation
Investigational New Drug Application
•What are the FDA requirements for pre-clinical studies?
•What is an Investigational New Drug Application?
•Do I need to submit an Investigational New Drug Application?
•Where do I get the necessary updated forms?
•Are there instructions to help you fill out the forms?
•When will I be assigned an IND number?
•When can I start clinical trials?
•Do I need to fill out a Statement of Investigator Form 1572?
•What is an Institutional Review Board?
•Does a physician, in private practice, conducting research with an FDA regulated product, need to obtain IRB approval?
•Does a clinical investigation involving a marketed product require IRB review and approval?
•Do I need informed consent?
•What are the specific divisions and contacts in CDER who can answer my questions?
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 이전글 |
CDER Regulatory Applications - Investigational New Drug and New Drug Application |
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 다음글 |
New Drug Application (NDA) |
