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PET drug producers under gun to meet FDA rule

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The clock is ticking for producers of drugs used in positron emission tomography (PET) to file drug applications with the FDA. The agency has posted some guidance to help them prepare, reports in-PharmaTechnologist. All PET drug producers have until June 12 to file a new or abbreviated drug application, or find an approved supplier that has filed an application and that complies with current good manufacturing practices (cGMPs), the FDA says in its final guidance. The applications were supposed to be filed by Dec. 12, but the FDA is offering 6 months of leeway before it begins enforcing the regulations. The new requirements have been under consideration for two years. The document also provides for producers the ABCs of how to set up and conduct a media fill to test production procedures. Story | Final guidance (PDF)