Posted By
Laura Morley
25-Jun-2019 07:05
Found In
Egroup:
Regulatory Open Forum
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Hello, I'm interested to hear your thoughts regarding the removal of an old formulation of a tablet (used in early phase clinical trials) from an IND, and the risks of doing so from the FDA's perspective. If one has received assurances that this formulation will not be used in future studies, and ...
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