Coalition Sponsors Session on FDA Topics

The Coalition for PET Drug Approval recently sponsored a session focused on FDA topics for PET drug manufacturers. The session was held at the 2014 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis. The session drew more than 100 attendees, representing academic PET drug manufacturers, commercial PET drug manufacturers, FDA representatives, and others. Five speakers covered a range of topics including Coalition activities, ANDA/NDA submission considerations, how to handle FDA inspections, and post-approval commitments for NDA and ANDA holders. The presentations generated numerous questions from the audience, including discussions of next steps and potential sessions at next year’s annual meeting of the SNMMI.

In case you missed the session, the presentations are available here:

We hope the session was helpful for the PET community and we welcome your feedback. If you have any comments or questions related to the presentations or the sessions, please contact the Coalition at the link above or leave a comment below.

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A Passion for Policy

By: Ashley Mishoe, PharmD

brendaBrenda 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 Meeting, Brenda announced her retirement from the United States Food and Drug Administration (FDA) and pursuit of new opportunities in the private sector. I am excited to share her story because of her key role in shaping the PET drug community we have today.

Dr. Uratani first began her career with the FDA as a review microbiologist in the Office for New Drug Chemistry within the Center for Drug Evaluation and Research (CDER). Her primary focus in this position was reviewing new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and critically evaluating investigations and validation studies regarding sterile drugs. She tells me that her background in experimental design and her studies in microbiology became quite helpful in understanding the types of contaminants possible, pinpointing the origins of potential contaminants, and determining appropriate end-product testing.

Enter 1999 and a decade that would completely change Brenda’s career (not to mention add a lot more pages to her curriculum vitae). That year, Dr. Uratani was assigned to the FDA’s mandate of developing good manufacturing practices (GMPs) and guidance documents for a new (and vastly different) area—PET drug manufacturing. She tells me that when she was first assigned to this project, she knew nothing about PET drugs or the PET community. However, Brenda made it her goal to become more familiar with the processes and the inherent issues involved in PET drug manufacturing. She visited more than ten manufacturing facilities in her first year (including those in research, commercial, and academic settings), and she spent countless hours studying the processes involved and asking questions along the way. As the draft GMPs started to take form, Dr. Uratani led FDA-initiated public meetings, where she acted as a key liaison between the FDA and the PET community.

I know what you’re thinking. Creating GMPs for one country is definitely a big enough goal to fill a person’s career. For the average person, you are probably right. But not for her; no, not for Brenda. Why take on one country, when you could tackle two? And by “two,” I mean she also conquered China. From 2009 to 2011, Dr. Uratani was appointed as the Assistant Country Director for the FDA’s analysis of the China FDA (SFDA). In this position, she served as the FDA’s liaison in China, where she influenced the Chinese government as they were revising and developing new GMPs for sterile drug products and also screened drugs to be exported. While Brenda enjoyed her experiences abroad, after two years, she was ready to return to the States. She didn’t return empty-handed, though; she brought with her a newfound knowledge of international trade and a better understanding of foreign policy and drug manufacturing abroad.

Skills. Brenda obviously has them, and I wanted to know what she thought were the most crucial skills when formulating new policies. Her answer was not surprising, and it was one that should be applied to all aspects of life. “Active listening and teamwork,” Brenda explains, “are critical in policy development.” Some of the experiences that taught her the most were listening carefully to the concerns of stakeholders in the PET community, understanding the paradigm shift the leaders were facing, and fully grasping the inherent safety concerns surrounding PET drugs. Brenda says that the most cherished part of her job was overcoming the challenges that arose when working with the PET community, and she adds that she is most gratified by the outcome of the PET regulations.

Because of her dedication to the field of PET, I was also anxious to hear Dr. Uratani’s thoughts for the future of PET drug manufacturing. Fortunately, she thinks that it is very bright, and she tells me that it is gratifying to reflect on how far the standards have come since the draft GMPs. I can hear the pride in her voice as she admits that she considers PET her “baby” and that she has enjoyed watching the PET community grow and develop into the relatively mature field it is today.

Although she is passionate about policy formation, Dr. Uratani recently left her career at the FDA to pursue new goals. She now works for Genentech Roche as a Senior Principal Tech Advisor. Brenda has fond memories of her days with the FDA; however, she is also excited to be starting something new.

Ultimately, the PET community is grateful for her contributions to the field, her dedication to quality standards, and for her unwavering support. She may not be with the FDA any longer, but she leaves behind a legacy as their expert in PET GMPs—a legacy that will always be remembered.

Her heart, her passion, her effort—it was GMPs, it was ensuring the safety of PET drugs for patients, and it was fighting for appropriate PET drug manufacturing standards. Brenda’s mission was creating policies that would simultaneously protect patients while enabling the growth of a new industry, and this mission resulted in an unparalleled set of quality standards for PET drug manufacturing. For these things, and in the name of patients who benefit from PET drugs every day, we are thankful and are fortunate to have had such a strong, dedicated person like Brenda. Good luck, Brenda!

My name is Ashley Mishoe. I am a PET nuclear pharmacist, a follower of all things GMP, and I am thankful for the work of Brenda.

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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, including applications submissions, review, and compliance with good manufacturing practices, inspections, registrations/listing and user fees.

For the complete Federal Register notice, please click on the following:
http://www.gpo.gov/fdsys/pkg/FR-2012-12-04/html/2012-29157.htm

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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 applications (INDs).

For the complete Federal Register notice, please click on the following:
http://www.gpo.gov/fdsys/pkg/FR-2012-12-04/html/2012-29163.htm

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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. Continue reading

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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. Continue reading

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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”. Continue reading

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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. Continue reading

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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”. Continue reading

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