Monthly Archives: October 2011

FDA POSITION ON INDS FOR PET DRUGS IN CLINICAL TRIALS

Posted on October 27, 2011 by C. Kubler

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.

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FDA ISSUES DRAFT GUIDANCE ON MEDIA FILLS OF ASEPTIC PREPARATIONS FOR PET DRUGS

Posted on October 6, 2011 by C. Kubler

The Food and Drug Administration (FDA) has issued a draft guidance entitled “Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs”.

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