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

Posted on April 11, 2012 by

The FDA has released the final Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs. Continue reading →

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FDA ISSUES DRAFT GUIDANCE ON INDS FOR PET DRUGS

Posted on February 14, 2012 by

The FDA has announced the availability of a draft guidance document entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”.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

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FDA TO OFFER WEBINAR ON SPL FOR PET MANUFACTURERS

Posted on February 3, 2012 by

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. Continue reading →

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FDA ISSUES FAQ GUIDANCE FOR CGMP FOR PET DRUGS

Posted on February 2, 2012 by

UPDATE: FDA has posted new draft guidance – FDA Oversight of PET Drug Products, Questions and Answers.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

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FDA TO OFFER WEBINAR ON CGMP FOR PET DRUGS

Posted on December 21, 2011 by

The Food and Drug Administration (FDA) has announced a webinar on CGMP for PET drugs. Continue reading →

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FDA ANNOUNCES MEETING ON GENERIC DRUG USER FEE ACT

Posted on December 8, 2011 by

The FDA has announced a public meeting to discuss the proposed Generic Drug User Fee Act. Continue reading →

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ADDITIONAL INFORMATION PROVIDED BY FDA

Posted on December 7, 2011 by

In response to an inquiry, the Food and Drug Administration (FDA) has answered several remaining questions. Continue reading →

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