ESTABLISHED IN 2010
The Coalition of PET Drug Manufacturers
We bring academic and commercial manufacturers together to advance scientific and regulatory principles associated with the manufacturing of safe and effective PET drugs.
150+
U.S. PET manufacturing facilities in our community
2010
Founded at the FDA’s request to unite academic and commercial producers
700
Attendees at the 2023 FDA PET Drugs Workshop we co-hosted
0.014%
Sterility OOS rate across 628,511 batches — our data, presented at SNMMI
WHAT WE DO
An interface between FDA and the people who make PET Drugs
Advocate
Formal comments and letters to DFA and USP on Part 212, USP ,823., stablity policy and inspection inconsistency.
— Comment letters
— Position papers
Educate
The Summit, FDA workshops, SNMMI symposia, and member webinars.
— Webinar library
— 2023 FDA Workshop videos
About the Coalition →
Equip
A curated library of regulations, guidance, publications and training — the clearinghouse for PET GMP.
— 21 CFR 212 & guidance
— Coalition Publications
Featured event
PET Drug Manufacturers Summit 2026
A peer-led, interactive forum to identify systemic barriers and co-create a unified roadmap for the field. Manufacturers only, with no regulators in the room.