Genomics Guidances, Concept Papers, and MaPPs

 

• Guidances  

• Concept Papers

• MaPPS (Manual of Policies and Procedures) 

Guidances

Pharmacogenomic Data and Labeling

Year	Draft	Guidances	Center
2005		Pharmacogenomic Data Submission (PDF - 96KB)	CDER, CBER, CDRH
2006		Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings (PDF - 73KB)	FDA, EMEA, EC
2006		EU (European Commission and EMEA) and FDA Agree on Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings	FDA, EMEA, EC
2007	X	Pharmacogenomic Data Submission - Companion Guidance (PDF -211KB)	CDER, NCTR, CBER, CDRH
2008		E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (PDF - 90KB)	CDER, CBER, ICH
	X	E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions (PDF - 135KB)	CDER, CBER, ICH
2009	X	Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (PDF - 144KB)	CDER, CBER
2011	X	Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (PDF - 531KB)	CDER, CBER, CDRH

Clinical Pharmacology and Drug Metabolism

Year	Draft	Guidances	Center
1997		Drug Metabolism/ Drug Interaction Studies in the Drug Development Process: In Vitro (PDF - 109KB)	CDER, CBER
1999		In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44KB)	CDER, CBER
2006	X	Drug Interaction Studies - Study Design, Data Analysis, and implications for Dosing and Labeling (PDF - 253KB)	CDER, CBER
2009		Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB)	CDER, CBER

Clinical Trial Design

Year	Draft	Guidances	Center
2010		Clinical Safety Review of an NDA or BLA (MAPP) (PDF - 816KB)	CDER
2010	X	Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 436KB)	CDER, CBER
2010	X	Chronic Hepatitis C Virus Infection: Developing Direct-Acting Agents for Treatment (PDF - 306KB)	CDER

Tests and Assays

Year	Draft	Guidances	Center
2005		Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems (PDF - 60KB)	CDRH
2005		Class II Special Controls Guidance Document: CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Gene Mutation Detection Systems	CDRH
2005		Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System	CDRH
2007		Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis	CDRH
2007		Pharmacogenomic Tests and Genetic Tests for Heritable Markers (PDF - 66KB)	CDRH, CDER, CBER
2007	X	In Vitro Diagnostic Multivariate Index Assays (PDF - 72KB)	CDRH, CBER
2007		Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF - 139KB)	CDRH, CBER
2011	X	In Vitro Companion Diagnostic Devices (PDF - 134KB)	CDRH

 
General

Year	Draft	Guidances	Center
2000		Formal Meetings With Sponsors and Applicants for PDUFA Products (PDF - 30KB)	CDER, CBER