Monthly Archives: February 2011

COALITION FOR PET DRUG APPROVAL FORMULATES QUESTIONS FOR FDA, SERIES #1

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.

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SPL TRAINING SESSION – POSITRON EMISSION TOMOGRAPHY (PET) DRUG SPL

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. 

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WHAT IS A PET SCAN?

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

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PET DRUGS PROPOSED CGMP RULE AND DRAFT GUIDANCE Q&As

The FDA recently published a series of questions and answers related to PET drugs and the CGMP rule and draft guidance.

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