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CDER Regulatory Applications - Investigational New Drug and New Drug Application
분류 Investigational New drug application 조회 2428
발행년도 2013 등록일 2015-07-27
출처 FDA (바로가기)
CDER Regulatory Submissions
 
Investigational New Drugs (INDs)
- Initial INDs (Research/commercial)
- Amendments
- Special Protocol Assessments (SPAs)
New Drug Applications (NDAs)
- Original NDA submissions
- Commitments/protocols
- Supplements
- Annual Reports
Drug Master Files (Types I, II, III, IV, and V)

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리스트 이전글과 다음글
이전글이전글 Guidance Investigational New Drug Application for Positron Emission Tomography (PET) Drugs
다음글다음글 Small Business Assistance: Frequently Asked Questions on Drug Development and Investigational New Drug Applications