The purpose of the Coalition of PET Drug Manufacturers (CPDM) is to help our community understand requirements related to the implementation of 21 CFR Part 212 and the submission process for PET NDAs or ANDAs, and to make a positive impact on the overall implementation process through interaction with the FDA.
Our vision is to be the nationally recognized entity for educational, scientific, and regulatory information on PET drug manufacturing under 21 CFR Part 212.
The CPDM is a venue for the PET drug manufacturing community to advance scientific and regulatory principles associated with the manufacturing of PET drugs. The key elements of this mission are to:
- Provide a multi-stakeholder forum to address current topics with government agencies and other groups
- Establish scientifically sound and rational practices for PET drug manufacturing
- Provide education and training
- Enable the expansion of new PET drugs into routine manufacturing networks
- Provide high-value resources to assist PET Drug Manufacturers with GMP compliance and inspection challenges
- Align the interests of the community of PET Drug Manufacturers