FDA 허가 프로세스 505(b)(2) 경로, 이것은 무엇인가요? Pre-IND와 NDA제출(Submission)은 무엇을 의미하나요?

Presented by

Ken Phelps 회장 & 창립자

About this talk

- 505(b)(2) 제품 식별 - pre-IND 및 NDA 준비 및 제출을 포함한 505(b)(2) 제품에 대한 임상 규정 마일스톤 탐색 - 505(b)(2)와 관련된 자주 묻는 질문(FAQ)과 일반적인 오해 해결

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