DOCUMENTS INCLUDE AN EXTENSIVE SLIDE DECK AND PROPOSED Q & A
The FDA has been quite busy since the issuance of the new 21 CFR 212 entitled “Current Good Manufacturing practice for Positron Emission Tomography Drugs” (December 2011) which covers Positron Emission Tomography (PET) Drug Products. CDER has issued a new Draft Guidance as well as a slide deck from B. Uratani, Ph.D. These documents are:
Guidance for Industry FDA Regulation of PET Drug Products — Questions and Answers (February 2012) — Draft Guidance
Current Good Manufacturing Practice for PET Drugs – CGMP 21 CFR 212 (Slide Presentation, February 2012)
These two new documents, issued within the past month, are designed to clarify how Companies manage their Application Submission, INDs and ANDAs. They also discuss the Chemistry, Manufacturing and Controls (CMCs) to include Stability and Sterility Testing. Current Good Manufacturing Practices (cGMPs) are also reviewed. Particular attention should be given to Quality Control of the chemistries and microbiology and the issue of Growth Promotion testing of media which markedly differs from what is required per USP<61>, <62> and <71>. It also notes that ANDAs may not be submitted for PET drugs other than FDG, Ammonia N13 and Sodium Fluoride F18. Please note that the Draft Guidance for Industry FDA Regulation of PET Drug Products Questions and Answers is currently outstanding and awaiting comments. The slide presentation, entitled Current Good Manufacturing Practice for PET Drugs – CGMP 21 CFR 212 is presented by Brenda Uratani, Ph.D., who was previously involved in other PET documents and quite instrumental in developing the FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (September 2004).
Several areas of particular note include “Exceptions” wherein provisions of USP Chapter<823> apply when PET drugs are produced under Investigational New Drug Application (IND) and Radioactive Drug Research Committee (RDRC). In either case IND and RDRC holders are not required to register and list PET drugs.
Other documents one should remain aware of include:
Guidance for Industry PET Drug — Current Good Manufacturing Practice (CGMP) December 2009
Positron Emission Tomography (PET): Questions and Answers about CGMP Regulations for PET Drugs (December 2009)
PET Drug Applications — Content and Format for NDAs and ANDAs (February 2011) — Draft Guidance
Guidance for Industry Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs (September 2011) — Draft Guidance
Investigational New Drug Applications for PET Drug — Draft Guidance (Not Yet Issued)
PET Drug Applications — Content and Format for NDAs and ANDAs (February 2011) — Draft Guidance
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