Important Change to NDA 021870

The Coalition would like to make PET drug manufacturers aware of a change to an FDA-approved application for Fludeoxyglucose F 18 Injection (FDG). This modification involves the radioactivity concentration (strength) for FDG described in new drug application (NDA) 021870, which is held by the Feinstein Institute for Medical Research. This change only applies to NDA 021870 and became effective on July 9, 2015. Specifically, the change was to increase the maximum radioactivity concentration from 300 mCi/mL to 400 mCi/mL.

While the modification may not seem significant at first glance, it raises the question of the potential impact on abbreviated new drug applications (ANDAs) that reference NDA 021870. To address this question, members of the PET community have contacted the FDA Office of Generic Drugs (OGD) for clarification. In response, OGD stated that it is not necessary to change the radioactivity concentration in ANDAs that reference NDA 021870. Consequently, no revisions to the product label are required for these ANDAs, nor is it necessary to perform new stability studies.

However, the change allows for an increase in the concentration of FDG up to 400 mCi/mL for ANDAs that reference NDA 021870. If an ANDA holder elects to change the concentration of the product described in their application, applicants are advised that changes to their specific product would require new stability studies, as well as an updated label that is revised as part of a prior approval supplement. In the communication from OGD, they noted that a suitability petition is not required to support a concentration up to 400mCi/mL.

Thanks to Dan Yokell at Massachusetts General Hospital and Bob Wolfangel at Certis International for bringing this information to the attention of the Coalition. The Coalition will share further information on this topic as necessary.

More information on NDA 021870 may be found on the FDA’s “Drugs@FDA” website at this URL.  In the search window, type 021870 to access the NDA.

More information on prior approval supplements may be found in the post entitled, “Sponsored Session from SNMMI Annual Meeting: Current Topics in FDA Reviews and Inspections of PET Drug Manufacturers,” that appeared on the Coalition’s website on June 25, 2015 (see below).

Questions? Please leave a comment in the comments section below.

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Coalition Comments on Generic Drug User Fee Act

The Coalition for PET Drugs submitted comments to the U.S. Food and Drug Administration (FDA) on the reauthorization of Generic Drug User Fee Act (GDUFA).  In general, the Coalition supports GDUFA and believes that user fees have successfully provided the FDA with the resources necessary for timely review of applications for typical generic drug products.

View the entire letter here »

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Slide Presentations from “FDA: Imaging Drug Development – Regulatory Issues” CE Session

The Coalition is following up on a message that we posted on May 29. In that posting, we highlighted a session at the recent SNMMI annual meeting entitled “FDA: Imaging Drug Development – Regulatory Issues.” The session was sponsored by the Health Policy and Regulatory Affairs group at SNMMI. For more information about the session, take a look at the May 29 posting.

Today, the Coalition would like to make you aware that the presentations from this session are now available on the FDA website. So, in case you missed the session or would like to review the presentations, here is the URL:

http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/
Oncology/ucm093322.htm#presentations

If you have any comments or questions related to the session, please contact the Coalition at the link above or leave a comment below.

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Sponsored Session from SNMMI Annual Meeting: Current Topics in FDA Reviews and Inspections of PET Drug Manufacturers

As we have done in past years, the Coalition for PET Drug Approval recently sponsored a session focused on FDA topics for PET drug manufacturers. The session was held at the 2015 annual meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in Baltimore. For the first time, the session was co-sponsored with the Radiopharmaceutical Sciences Council (RPSC) of the SNMMI. This is an important development as it demonstrates the alignment of the Coalition’s mission with that of the RPSC. Although the two groups have seemingly divergent missions, they share the goal of supporting a science-based approach to regulatory issues. This is a very exciting collaboration!

The session also included an additional ad hoc meeting to discuss recent developments at the US Pharmacopeia that are pertinent to PET drug manufacturers and nuclear medicine in general. The session drew more than 125 attendees, representing academic PET drug manufacturers, commercial PET drug manufacturers, FDA representatives, and others.

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

1. Steve Zigler – Session Outline
2. Steve Mattmuller – Small Entity Perspective
3. David Wilson – Commercial Perspective
4. Michael Nazerias – Reporting Changes to Approved NDA or ANDA
5. Eric Webster – Sterility Assurance Program for PET Drugs
6. Zigler-Ravichandran – USP Update

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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Important Upcoming Events at SNMMI Annual Meeting in Baltimore

The Coalition would like to make you aware of some important events at the upcoming SNMMI annual meeting in Baltimore. We hope you can attend!

On Friday, June 5 from 9 to 10 am in the room Ruth in the Baltimore Hilton Hotel, the Coalition, led by Sally Schwarz, R.Ph. and Henry VanBrocklin, Ph.D., will hold a public meeting to review activities over the last year and to discuss future directions.

The Coalition is co-sponsoring a CE session with the Radiopharmaceutical Sciences Council (RPSC) on Monday, June 8, in Room 317 of the Baltimore Convention Center. The title of this session is “Current Topics in FDA Reviews and Inspections of PET Drug Manufacturers.” The session runs from 4:45 to 6:15 pm and includes the following presentations:

  • Current topics in FDA reviews and inspections from the perspective of a small entity, Steve Mattmuller, MS, RPh, BCNP
  • Current topics in FDA reviews and inspections from the commercial perspective, David Wilson, BS, RPh
  • Reporting changes to an approved NDA or ANDA, Michael Nazerias, M.S.
  • Overview of a sterility assurance program for PET drugs, Eric Webster

An additional session has recently been added to the program. The additional session is entitled “Update on Current Topics at the USP” and takes place immediately after the previous session on Monday, June 8, in Room 317 of the Baltimore Convention Center. The goal of the new session is to provide an update on the latest activities at the USP related to PET drug monographs and the revision of general chapters for PET drugs and radioactivity. In addition, information will be provided for the next revision cycle and future directions at the USP. The session runs from 6:20 pm to 6:50 pm and includes the following presentations:

  • Brief update on USP monographs for PET drugs, Steve Zigler, Ph.D.
  • Progress on general chapters pertinent to nuclear medicine, Steve Zigler, Ph.D.
  • Update on new revision cycle 2015-2020, Ravi Ravichandran, Ph.D.

Finally, a session entitled “FDA: Imaging Drug Development – Regulatory Issues” takes place on Tuesday, June 9, from 10:00 am to 11:30 am in Room 318-319 of the Baltimore Convention Center. This session is sponsored by the Health Policy and Regulatory Affairs group at SNMMI and includes the following presentations:

  • Chemistry, manufacturing, and control (CMC) issues in applications, Ravi Kasliwal, Ph.D.
  • Nonclinical requirements for low dose diagnostic agents: past, present, and envisioning the future, Adebayo Laniyonu, Ph.D.
  • Efficacy considerations for imaging product approval, Louis Marzella, MD, Ph.D.
  • Statistical aspects of evaluating diagnostics, Thomas Gwise, Ph.D.
  • PET products: case histories and inspectional updates, Krishna Gosh, Ph.D.
  • Ge-68/Ga-68 Generators – FDA perspective, John Amartey, Ph.D.
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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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