Title 21CFR applicable to Phase1, Phase 2 clinical trials

[alCurtal]

#25474

Dear stabilitarians,

Could you please help me understand if the following claims are true or false?
Not all 21 CFR part 211 are applicable to Phase 1 and Phase 2 clinical trials. Only the 21CFR that are clearly stated for investigational new drugs are applicable for Phase 1 and Phase clinical trials. For example, 21CFR part 211.166, 211.137 may not apply to Phase 1 and Phase 2 clinical trials. 21CFR part 312 is applicable to Phase 1 and Phase 2 clinical trials.
What are the 21CFR applicable to early phase clinical trials such as Phase 1 and Phase 2?
Thanks so much!

[John O’Neill]

#25492

I’ve delayed a while before replying, hoping to see someone swoop in with some official references. I haven’t seen them, but I recall that back in the day, we utilized “GMP exemptions” in our early clinical phases. Be sure to float anything you wish to exempt by your internal regulatory folks, or better yet, the regulatory authorities in early meetings regarding your product’s registration pathway.

[Author]

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