Home Forums General Discussion Title 21CFR applicable to Phase1, Phase 2 clinical trials Reply To: Title 21CFR applicable to Phase1, Phase 2 clinical trials

John O’Neill
Moderator
Post count: 75

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.