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Hi everyone, Please advise if there are specific FDA guidances that outline CMC filing requirements for professional samples or share your industry experience. I have seen a few different approaches adopted, from filing as a NDA supplement and in an annual report, to some peers suggesting they don't ...

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 ...

Hi Bridgette,  That's great - I appreciate you taking the time to respond. ------------------------------ Laura Morley Senior Regulatory Affairs Associate CMC Foster City CA United States ------------------------------

Hello everyone,  Is it possible to continue cross-referencing to information contained in an IND that has been made inactive? If said IND was the parent IND for nonclinical/clinical or CMC information, but deveIopment for that indication will be discontinued, I assume just before that IND is terminated ...

------------------------------------------- Original Message: Sent: 12-Apr-2019 10:53 From: Anonymous Member Subject: Inclusion of another company's investigational product in a clinical trial - regulatory considerations This message was posted by a user wishing to remain anonymous Assuming ...