Reminder: Two-year post approval inspections

The Coalition would like to share some important reminders with PET Drug manufacturers that may be coming up on their two-year post approval inspection. Below is a list of items FDA inspectors recently asked for in one of the current inspections. This serves as a reminder to make sure you have all of your GMP documentation and reports up to date and ready for your FDA inspection.

  1. Organizational Chart
  2. Position/job description for each personnel in the facility
  3. Bill of lading (interstate shipment document; 18O-H2O)
  4. Table of contents for all SOPs
  5. Out of specification investigations and follow-up for the past 24 months
  6. Floor layout with air specification labeled for each room
  7. SOP-LAFW qualification report (Vendor annual qualifications and reports)
  8. SOP-equipment qualification and maintenance of main instruments involved with production + analytical procedures
  9. SOP- Environmental, Personnel
  10. SOP-Personnel training and aseptic technique training records
  11. SOP-ISO 5 cleaning area
  12. SOP-Media Fill and qualification of personnel records
  13. SOP-Vendor qualification
  14. SOP-Microbiological media qualification
  15. SOP-Manufacture batch/QC records for the past 24 months
  16. SOP-Stability test
  17. SOP-Document Change records
  18. SOP- Out of Specification
  19. SOP- Manufacture and QC methods
  20. SOP- Procedure for actions taken for any sterility failures.
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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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