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Monthly Archives: October 2011
FDA POSITION ON INDS FOR PET DRUGS IN CLINICAL TRIALS
Recent questions posed to the FDA regarding the requirement for INDs for PET drugs used in clinical trials has drawn a clarifying response from the FDA on its position.
Posted in PET Drugs
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FDA ISSUES DRAFT GUIDANCE ON MEDIA FILLS OF ASEPTIC PREPARATIONS FOR PET DRUGS
The Food and Drug Administration (FDA) has issued a draft guidance entitled “Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs”.
Posted in PET Drugs
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