Resources
Welcome to the PET Drug Manufacturers Coalition Resource Library.
To explore available materials, please click a category below to jump to that section of the page, or simply scroll through:
Coalition Presentations at SNMMI Meetings
“SNMMI: For PET drugs, sterility assurance bests sterility testing” - Steve Zigler’s talk, Sterility Assurance of Manufactured PET Drugs, caught the attention of a writer at AuntMinnie.com, who published the above article. An excerpt follows:
Sorting out 10 years of data from 2013 to 2023, the team found that there were 628,511 batches of PET drugs reported. Of them were 87 sterility test out-of-specification (OOS) results (that is, batches that do not meet established standards or specifications). Required OOS investigations found an OOS rate of 0.014%, Zigler noted, adding that the rate is well below the FDA's expected sterility test failure rate of 0.05%, a rate included in the PET GMP final rule from 2009. "This allows us to estimate the 'sterility assurance level' for diagnostic PET drugs," Zigler said. "Assuming that all those 87 [out-of-specification incidents] were actually true product failures, which they were not, that would lead to a sterility assurance level, or SAL, of at most 1.4 in 10,000 batches. That's much better than the accepted SAL for aseptically processed nonradioactive drugs."
Download the “Sterility Assurance” slides
"Assessment of PET Drug Adverse Events over the Last Half Century” - A Coalition poster presentation won the Molecular Targeting Probes First Place Poster Award. The poster (ID 251366) was authored by Marianna Dakanali, PhD (University of Michigan, presenting author); Peter Scott, PhD (University of Michigan); Henry VanBrocklin, PhD (UCSF); and Steve Zigler, PhD (PETNET Solutions Inc., a Siemens Healthineers Company). This poster received a First Place award in the category of Molecular Targeting Probes.
Coalition Publications
Proceedings: PET Drugs—A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerations - JNM article of the proceedings of the 2023 FDA PET Drugs Workshop. Also, don’t miss the Supplemental Material.
Proceedings: PET Drugs: A Workshop on Inspections Management and Regulatory Considerations - JNM article of the Proceedings of the 2020 FDA PET Drugs Workshop
Radiopharmaceutical Visionary: Krishna Ghosh’s Transformative Role at the FDA - Article written by Steve Zigler, Ashley Mishoe, and Sally Schwarz following a May 2025 interview with Dr. Krishna Ghosh. A widely recognized figure in the PET manufacturing community, Dr. Ghosh recently retired from her role as Senior Policy Advisor at the FDA after 15 years of shaping PET drug regulation. Her work revolutionized the industry through scientific leadership and regulatory innovation.
PET Drugs Workshop Presentations/ Videos
PET Drugs—A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerations - The proceedings paper from the 2023 FDA workshop has been published in The Journal of Nuclear Medicine. Authored by several Coalition members, the paper represents a significant collaborative effort and provides valuable insights for the PET manufacturing community.
PET Drugs Workshop (Nov 13-14, 2023), link to access presentation videos and PDFs - In November 2023, the Coalition oPET Drugs—A 2023 Workshop on Product Quality, Regulatory Submissions, Facility Inspections, and Benefit–Risk Considerationsf PET Drug Manufacturers, Medical Imaging & Technology Alliance (MITA), and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) co-hosted a high-attendance workshop with the FDA focused on PET drug regulation. The two-day event provided a forum for academic and commercial PET drug manufacturers to engage directly with the FDA on topics such as product quality regulatory submissions, facility inspections and compliance, benefit-risk considerations, control and safety issues, and emerging regulatory trends. The recurring workshop fosters collaboration among more than 150 U.S. PET drug facilities and research institutions, aiming to address challenges, explore solutions, and support a sustainable supply of PET drugs. Presentation videos and PDF materials are available for review using the link above.
PET Drugs: A Workshop on Inspections Management and Regulatory Considerations (February 2020) - The workshop was attended by radiopharmaceutical scientists, nuclear pharmacists, regulatory affairs professionals, and compliance specialists with expertise in PET drug manufacturing. Attendees represented academic institutions, commercial suppliers, contract manufacturers, and innovators involved in the development of new PET drugs. Many representatives from the FDA also attended. Approximately 150 attendees participated in-person and numerous participants joined in a live video broadcast of the event. The presentations and a recording of the workshop are currently available on the FDA’s website.
Coalition Comments to Regulatory Entities
”Recent FDA Policy Changes on Stability Studies for PET Drugs” - At the 2023 FDA PET Drugs Workshop, the Coalition observed a shift in inspection practices: FDA inspectors began requiring annual stability testing at each PET drug manufacturing facility, deviating from the long-accepted “one stability, one facility” protocol. In response, the Coalition issued a position paper clarifying that this requirement is not explicitly supported by current PET GMP regulations or FDA guidance. The paper outlines the potential impact of this change on the U.S. PET drug supply.
Coalition Comments on FDA’s Draft Report and Plan on Best Practice for Guidance - On February 26, 2024, the Coalition submitted formal comments developed by a working group and approved by the Board. The Coalition urged the FDA not to implement automatic Level 1 and 2 Guidance impacting PET drug manufacturing and regulatory submissions at this time, instead requesting ongoing engagement through review cycles and comment periods. The Coalition reaffirmed its commitment to timely, effective processes supporting safe and available diagnostic radiopharmaceuticals.
Coalition Comments on Proposed Revision to USP Chapter <823> - On January 30, 2024, the Coalition submitted comments developed by a working group and approved by the Board. The Coalition supports removing “compounding” from USP <823> but opposes many other proposed revisions, citing lack of justification and potential to hinder innovation and growth in PET drug manufacturing. The revisions could negatively impact all PET manufacturers, especially new product development.
Regulatory Documents
FDA Final Report and Plan on Best Practices for Guidance - In February 2024, the Coalition submitted comments to the FDA’s “Draft Report and Plan on Best Practices for Guidance,” as did over 30 other entities. The linked final report considered this input.
FDA Briefing Document, “PET Diagnostic Radiopharmaceutical Drugs” -
In August 2023, the Food and Drug Administration (FDA) convened an Advisory Committee meeting to discuss dosimetry data needed to support the initial clinical study in an original investigational new drug (IND) application for certain new PET drugs used in diagnostic nuclear medicine.In a Federal Register notification published on July 25, 2022 (link to PDF) and reported by Thompson FDA (link here), the FDA announced plans to expand its Remote Regulatory Assessment (RRA) program “across all FDA-regulated products beyond the current COVID-19 public health emergency.” The proposed guidance can be found under Docket FDA-2022-D-0810.
As part of its expansion of the Remote Regulatory Assessment (RRA) program, the FDA released a draft guidance titled “Conducting Remote Regulatory Assessments: Questions and Answers” (view draft guidance). To view the Coalition’s final comment letter click here.
Sameness Evaluations in an ANDA — Active Ingredients Guidance for Industry
eCTD Headings: The Comprehensive Table of Contents Headings and Hierarchy
21CFR212- Current Good Manufacturing Practice for Positron Emission Tomography Drugs
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-21221CFR11 - Electronic Records
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application21CFR361 - Radioactive Drug Research Committee (RDRC) Program
https://www.fda.gov/drugs/science-and-research-drugs/radioactive-drug-research-committee-rdrc-program21CFR312 —Investigational New Drug Application
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312?toc=17356.002P Inspections
https://www.fda.gov/media/82370/downloadGuidance - PET Drugs - Current Good Manufacturing Practice (cGMP)
https://www.fda.gov/files/drugs/published/PET-Drugs--Current-Good-Manufacturing-Practice-%28CGMP%29--Small-Entity-Compliance-Guide.pdfGuidance - FDA Oversight of PET Drug Products Q&A
https://www.fda.gov/files/drugs/published/FDA-Oversight-of-PET-Drug-Products----Questions-and-Answers.pdfGuidance - PET Drug Applications - Content and Format for NDAs and ANDAs
https://www.fda.gov/files/drugs/published/PET-Drug-Applications---Content-and-Format-for-NDAs-and-ANDAs.pdfGuidance - Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/media-fills-validation-aseptic-preparations-positron-emission-tomographyGuidance - Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-nonclinical-studies-and-labeling-recommendations-guidanceUSP 825 - https://www.usp.org/chemical-medicines/general-chapter-825
IAEA/WHO guideline on GMP (Annex 3) - https://www.who.int/publications/m/item/trs1044-annex3
ICH Guidelines - https://www.ich.org/page/ich-guidelines
Non-Manufacturing PET Guidance (FYI) — Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microdose-radiopharmaceutical-diagnostic-drugs-nonclinical-study-recommendations
Other Publications
Regulatory Requirements for PET Drug Production - https://jnm.snmjournals.org/content/55/7/1132
Using radiotracers under an RDRC - https://ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-020-00110-z
Radiopharmaceuticals for drug development - https://www.ingentaconnect.com/content/ben/crp/2008/00000001/00000001/art00002?crawler=true
FDA requirements for testing a new radiopharmaceutical - https://www.sciencedirect.com/science/article/pii/S0001299810000474?via%3Dihub
Harmonization of radiopharmaceutical regulations - https://jnm.snmjournals.org/content/60/2/158.short
Training Opportunities
SNMMI Quality Systems Personnel Training Program (QSPTP) - This comprehensive training initiative designed to prepare pharmacists and chemists to oversee the small-scale manufacture, quality control, and release of radiopharmaceuticals. The program includes in-depth online modules covering regulatory compliance, quality systems, radiochemistry, and nuclear physics, with an optional hands-on experiential learning component launching in Fall 2025. Ideal for PharmDs or individuals with a B.S./M.S. in pharmacy or chemistry, QSPTP equips participants with the cross-disciplinary knowledge required to serve as Qualified Persons in radiopharmaceutical production.