U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated. 02-Mar-20111Chemistry, Manufacturing, and Controls (CMC) – Content and Format for New PET DrugsRavindra K. Kasliwal, Ph.D.Division of New Drug Quality Assessment-IIIOffice of New Drug Quality AssessmentCDER / FDA02-Mar-20112Submissions for New PET Drugs• Submit in common technical document (CTD) format• Organization of CTD– Module 1 - Administrative information and prescribing information– Module 2 – common technical document summaries (M4Q, M4S, M4E)– Module 3 – Quality (chemistry, manufacturing, and controls)– Module 4 – Nonclinical study reports– Module 5 – Clinical study reports• Guidance for industry - M4: Organiz ation of the CTD– http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegul atoryInformation/Guidances/ucm073257.pdf02-Mar-20113M4Q - The CTD - Quality• Module 2 – Common technical document summaries.– Quality overall summary (summary follows the scope and the outline of the body of data in module 3)• Introduction (2.3)• Drug substance (2.3.S)• Drug product (2.3.P)• Appendices (2.3.A)• Regional information (2.3.R)02-Mar-20114M4Q - The CTD - Quality• Module 3 – Format of the quality (CMC) section.• CTD Quality Guidance– Guidance for industry - M4Q: The CTD — Quality(http://www.fda.gov/downloads/Drugs/GuidanceCompli anceRegulatoryInformation/Guidances/ucm073280.pdf)– Guidance for industry - M4: The CTD — Quality Questions and Answers/ Location Issueshttp://www.fda.gov/downloads/Drugs/GuidanceComplia nceRegulatoryInformation/Guidances/ucm073285.pdf02-Mar-201153.2.S DRUG SUBSTANCE3.2.S...
