• Compliance and Surveillance (PDF - 275KB)
• Current Good Manufacturing Practices for PET Drugs – Examples of Case Studies (PDF - 99KB)
• Microbiology/Sterility Assurance Information for PET Applications – NDAs & ANDAs (PDF - 93KB)
• PET Drugs: Submitting a New Drug Application (NDA) (PDF - 327KB)
• Submitting a PET Drug Investigational New Drug (IND) Application (PDF - 673KB)
• PET Products and User Fees (PDF - 107KB)
• Considerations for PET ANDAs (PDF - 193KB)
• NDA 505(b)(1) of the FD&C Act (PDF - 40KB)
• Chemistry, Manufacturing, and Controls (CMC) – Content and Format for New PET Drugs (PDF - 132KB)
• Submitting Chemistry, Manufacturing and Controls (CMC) Information in an ANDA / NDA for Commonly Used PET Drugs (PDF - 118KB)
• PET Drug Product BE Requirements for ANDA Submissions (PDF - 43KB)

Related Information

• Preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging; Public Meeting
  Back to Meeting Page