Drugs · May 5, 2021

Jon B. Cole, MD

1 extracted findings

FDA source excerpt, selected passage

Failure to submit INDs for the conduct of clinical investigations with investigational new drugs subject to 21 CFR 312.2(a) [21 CFR 312.20 and 312.40(a)].

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Selected FDA passages, not the complete letter.

Failure to submit INDs for the conduct of clinical investigations with investigational new drugs subject to 21 CFR 312.2(a) [21 CFR 312.20 and 312.40(a)].

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 312.2(b)(1)21 CFR 312.20 21 CFR 312.2(b)(1)(iii)21 CFR 31221 CFR 312.2(a)21 CFR 312.3(b)21 CFR 312.2 21 CFR 312.2(b)21 CFR 312.7 21 CFR 312.2(d)21 CFR 5621 CFR 50

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Jon B. Cole, MD

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