The Coalition is seeking feedback on issues of concern or outstanding questions regarding the 21 CFR Part 212 regulation.
The purpose of the coalition 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.
To fulfill this mission, the Coalition is asking PET manufacturers to submit questions that remain unanswered or concerns regarding the implementation and compliance with the CGMP for PET drugs. The Coalition will include these in communications with the FDA or order to benefit the community. To submit a question, please email Coalitionforpetdrugapproval@snm.org.