MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs.  The Comment period will be 90 days. Please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT document.