The Investigational New Drug (IND) and New Drug ...
The Investigational New Drug (IND) and New Drug Application (NDA) Process Susan Honig, MD Division of Oncology Drug Products. US Food & Drug Administration. Public Domain. Relevant Laws ... NDA. Submission. 45-day. filing meeting. 60-day. filing. Advisory . Committee. Meeting. Change . label. NDA… ................
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