Author Archives: C. Kubler

A Passion for Policy

By: Ashley Mishoe, PharmD Brenda Uratani. To those of us in the positron emission tomography (PET) community, this is a name associated with dedication to PET, a spirit of guidance, and a passion for safety. At the recent SNMMI Mid-Winter … Continue reading

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Coalition Submits Comments on ANDA Draft Guidance

The Coalition for PET Drug Approval submitted comments to the FDA on March 24 to address Improving the Quality of Abbreviated New Drug Application Submissions.

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FDA announces Q&A guidance on Oversight of PET Drug Products

On Tuesday, December 4, 2012, the Food and Drug Administration announced the availability of a guidance entitled, “FDA Oversight of PET Drug Products- Questions and Answers.” The Q &A’s cover almost all areas of the FDA approval and surveillance processes, … Continue reading

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FDA announces availability of IND applications for PET Drugs

On Tuesday, December 4, 2012, the Food and Drug Administration announced the availability of a guidance entitled, “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.” This guidance will support manufacturers of PET drugs in submitting investigational new drug … Continue reading

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FDA Approves Choline C11 Injection for Prostate Cancer Detection

The U.S. Food and Drug Administration (FDA) announced today the approval for the production and use of Choline C 11 Injection, a PET imaging agent used to help in the detection of prostate cancer.

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NORTH SHORE/LIJ HEALTH SYSTEM RECEIVES EXPANDED ACCESS IND

North Shore/LIJ Health System has recently received FDA approval of an expanded access IND for Fluorodopa F-18 PET for Parkinsonian diseases.

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COALITION SUBMITS COMMENTS ON DRAFT GUIDANCE

The Coalition for PET Drug Approval submitted comments to the FDA on the draft guidance entitled “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs”.

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

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

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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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