Monthly Archives: February 2012
The FDA has announced the availability of a draft guidance document entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”. Advertisements
FDA has scheduled a webinar to assist PET drug manufacturers prepare their SPL files prior to the new deadline. The webinar will be offered on April 23, 2012.
UPDATE: FDA has posted new draft guidance – FDA Oversight of PET Drug Products, Questions and Answers.