Resources
FDA Briefing Document—PET Diagnostic Radiopharmaceutical Drugs (PDF file)
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. The study concluded:
Recommended activity amounts for FIH studies with new PET drugs based on published human dosimetry data and regulatory experience depend on the radiation dosimetry profile of a given radiopharmaceutical (i.e., both physical and biological properties) and on the observed variability of estimated doses and AA values. In this review, we observed good agreement between animal-derived FDA Briefing Document—PET Diagnostic Radiopharmaceutical Drugs and human-measured dosimetry, especially in studies with PET drugs labeled with relatively short-lived radionuclides. Given the increased amount of clinical data available and the lower variability in dose estimates derived from clinical studies, we relied on data from PIs of FDA-approved drugs and published clinical studies to derive AA guidelines that can be used prior to performing dosimetry in a FIH study of an investigational PET drug labeled with F-18, C-11, Ga-68, Cu-64, Rb-82, and N-13. The proposed upper limits on AA for FIH studies with new PET drugs provide flexibility on the need to perform animal dosimetry studies for developing new radiopharmaceuticals labeled with one of these six PET radionuclides F-18, C-11, Ga-68, Cu-64, Rb-82, and N-13.
USP Proposed Changes to Chapter 823 (PDF file)
Sameness Evaluations in an ANDA — Active Ingredients Guidance for Industry (PDF file)
eCTD Headings: The Comprehensive Table of Contents Headings and Hierarchy (PDF file)
SNMMI Qualified Systems Personnel Training Program (QSPTP)
https://www.snmmi.org/QSPTP
21CFR212:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=212
21CFR11 - Electronic Records
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
21CFR361 - RDRC
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1
21CFR312 — INDs
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
7356.002P Inspections
https://www.fda.gov/media/82370/download
Guidance - 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.pdf
Guidance - FDA Oversight of PET Drug Products Q&A
https://www.fda.gov/files/drugs/published/FDA-Oversight-of-PET-Drug-Products----Questions-and-Answers.pdf
Guidance - 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.pdf
Guidance - 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-tomography
Guidance - 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-guidance
USP 825:
https://www.usp.org/chemical-medicines/general-chapter-825
Paper - Proceedings of Coalition Workshop:
https://jnm.snmjournals.org/content/early/2022/01/20/jnumed.121.263443
Paper — Regulatory Requirements for PET Drug Production
https://jnm.snmjournals.org/content/55/7/1132
Paper — Using radiotracers under an RDRC
https://ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-020-00110-z
Paper - Radiopharmaceuticals for drug development
https://www.ingentaconnect.com/content/ben/crp/2008/00000001/00000001/art00002?crawler=true
Paper — FDA requirements for testing a new radiopharmaceutical
https://www.sciencedirect.com/science/article/pii/S0001299810000474?via%3Dihub
Paper — Harmonization of radiopharmaceutical regulations
https://jnm.snmjournals.org/content/60/2/158.short
IAEA/WHO guideline on GMP (Annex 3)
https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current-projects/qas21_878_iaea_who_gmp_for_radiopharmaceutical_products.pdf?sfvrsn=6285a50a_3
ICH Guidelines
https://www.ich.org/page/ich-guidelines
Presentation — Current Good Manufacturing Practice for PET Drugs – CGMP 21.CFR.212
https://cupdf.com/document/cgmp-for-pet-drugs-21-cfr-212-cder-office-of-compliance-brenda-uratani-phd.html
Presentation — Current Issues Regarding Sterility Assurance Submissions for Sterile Generic Drug Products Dr. Lynne A. Ensor
https://docplayer.net/27303566-Current-issues-regarding-sterility-assurance-submissions-for-sterile-generic-drug-products-dr-lynne-a-ensor.html
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