FDA ISSUES DRAFT GUIDANCE ON MEDIA FILLS OF ASEPTIC PREPARATIONS FOR PET DRUGS

The Food and Drug Administration (FDA) has issued a draft guidance entitled “Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs”.

The draft guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency’s current good manufacturing practice regulations of PET drugs. The draft guidance, once finalized, will represent the Agency’s current thinking on media fills and process simulations for PET drugs.

Interested persons should submit comments through http://www.regulations.gov, Docket No. FDA-2011-D-0691, by December 29, 2011.

To view the draft guidance, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf

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