Resources
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