PET radiopharm reg reverses FDA policy on nuclear pharmacy, medical groups maintain.
This article was originally published in The Gray Sheet
Executive Summary
PET RADIOPHARMACEUTICAL REG "UNJUSTIFIABLY" REVERSES FDA POLICY, ASHP (the American Society of Health-system Pharmacists), the American Pharmaceutical Association and the American College of Nuclear Physicians/Society of Nuclear Medicine maintain in a July 27 joint letter to FDA Commissioner Kessler. The coalition wrote to express its "profound concern regarding the direction the FDA is taking in regulating PET (positron emission tomography) radiopharmaceuticals" as articulated in the agency's proposed reg on PET products.