Monthly Archives: February 2012

FDA ISSUES DRAFT GUIDANCE ON INDS FOR PET DRUGS

The FDA has announced the availability of a draft guidance document entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”.

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FDA TO OFFER WEBINAR ON SPL FOR PET MANUFACTURERS

FDA has scheduled a webinar to assist PET drug manufacturers prepare their SPL files prior to the new deadline. The webinar will be offered on April 23, 2012.

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FDA ISSUES FAQ GUIDANCE FOR CGMP FOR PET DRUGS

UPDATE: FDA has posted new draft guidance – FDA Oversight of PET Drug Products, Questions and Answers.

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