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Summary Building a CTD / MRF 1

Summary Building a CTD / MRF 1. Administrative. Application. Form. Index. Certifications - Part 1. Labeling. Labeling/Summary. (Annotated Package Insert) Part 1. Executive Summary. Integrated Analyses of Safety,. Effectiveness,. Benefits/Risk – Part 2A & B. Part 3. Part 4.

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Summary Building a CTD / MRF 1

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  1. SummaryBuilding a CTD / MRF 1 Administrative Application Form Index Certifications - Part 1 Labeling Labeling/Summary (Annotated Package Insert) Part 1 Executive Summary Integrated Analyses of Safety, Effectiveness, Benefits/Risk – Part 2A & B Part 3 Part 4 Part 5 Detailed Summaries Chemistry Nonclinical Human PK/ Pharmacology/ Bioavailability / Toxicology Establishment Description Clinical / Statistical Tabular Clinical Tabular Chemistry Tabular Nonclinical Reports Summaries Summaries Summaries Chemistry Data/Reports – Part 2C Nonclinical Full Reports Part 2E Clinical Full Reports Part 2D Data Nonclinical Clinical Case Clinical Chemistry Data (GMP) Report Forms Data (GCP) Data (GLP) Investigators Brochure to Package Insert – Part 1

  2. Discussion and Questions

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