Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs." This guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.