FDA New Guidance on PET Drugs GMPs

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Updated June 24, 2024

The original link broke.

You can still read about the same topic here:

Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP)  - FDA.gov

---  the original post follows below  ---

This FDA guidance, Guidance - PET Drugs — Current Good Manufacturing Practice (CGMP), is intended to help positron emission tomography (PET) drug producers better understand FDA’s thinking concerning compliance with the current good manufacturing practice (CGMP) regulations. The guidance addresses resources, procedures, and documentation for all PET drug production facilities, academic and commercial. In some cases, the guidance provides practical examples of methods or procedures that PET drug production facilities can use to comply with the CGMP requirements.

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