Draft Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs; Availability

PDA is pleased to offer comments on the draft guidance entitled "Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs". PDA is a non-profit international professional association of more than 10,000 individual member scientists having an interest in the fields of pharmaceutical, biological, and device manufacturing and quality. Our comments were prepared by a committee of experts with experience in the manufacture of Positron Emission Tomography Drugs, as well as manufacturing and validation of aseptically processed drug substance and drug products. The committee included members representing our Regulatory Affairs and Quality and Science Advisory Boards. PDA appreciates the opportunity to offer comments and wishes to thank FDA for the opportunity to do so.