Monthly Archives: February 2011

The Coalition for PET Drug Approval has compiled questions which they will be seeking answers to from the FDA. The answers will be posted for public review.

FDA’s Office of Critical Path has created a web-based training session to help applicants use SPL.  The first registration session is being offered on March 8. 

The Coalition for PET Drug Approval is working with members of the medical community to make sure that drugs used when performing a PET scan are licensed by the FDA. In order to do a PET scan you must use … Continue reading →

The FDA recently published a series of questions and answers related to PET drugs and the CGMP rule and draft guidance.