Hi Anon
This may depend on exactly what you're planning to do with the radiopharmaceuticals. Is it an investigational product? For example, see this list of phases in the development process:
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
https://www.fda.gov/drugs/development-approval-process-drugs
The GMP guidance may also be interesting.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-phase-1-investigational-drugs
Besides the FDA rules relevant to whatever type of product you're working on, make sure to check the applicable NRC rules:
https://www.nrc.gov/materials/miau/med-use.html
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Anne LeBlanc
United States
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Original Message:
Sent: 19-Jan-2024 12:03
From: Narayan Rao
Subject: GMP facility for radiopharmaceuticals
Please contact your FDA District office for any guidance!
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GRSAOnline
Original Message:
Sent: 18-Jan-2024 08:51
From: Anonymous Member
Subject: GMP facility for radiopharmaceuticals
This message was posted by a user wishing to remain anonymous
We are an academic institution who is looking to set up a GMP facility for the manufacturing of radiopharmaceuticals. We are a little unsure of if anything should be submitted to the FDA to prove that it will follow GMP. Does anyone have any advice?