Genomics at FDA - Guidances, Concept Papers, and MaPPs

Guidances

• Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings
  • EU (European Commission and EMEA) and FDA Agree on Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings. Public Statement
• Pharmacogenetic Tests and Genetic Tests for Heritable Markers
• Guidance for Industry: Pharmacogenomic Data Submissions
  • Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601"
• Pharmacogenomic Data Submissions — Companion Guidance (Draft)
• Guidance for Industry: Formal Meetings With Sponsors and Applicants for PDUFA Products
• Class II Special Controls Guidance Document: Instrumentation for Clinical Multiple Text Systems
• Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System

Concept Papers

• Drug-Diagnostic Co-Development - Preliminary Draft Concept Paper (4/8/2005)
• Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling - Preliminary Draft Concept Paper

Manual of Policy and Procedures (MaPP)

• Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG)
  MaPP 4180.2
• Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs)
  MaPP 4180.3