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)
|
|