Precision Medicine Resources
GENOMIC MEDICINE TOOLS AND DATA REPOSITORIES
GUIDANCE ON PRECISION MEDICINE RELATED REGULATORY SCIENCE
- Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
- Adaptive Design Clinical Trials for Drugs and Biologics
- Collection of Race and Ethnicity Data in Clinical Trials
- Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs
- Evaluation of Sex Differences in Medical Device Clinical Studies (Draft Guidance)
- Qualification Process for Drug Development Tools
- Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling
- Rare Diseases: Common Issues in Drug Development Guidance for Industry
- Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
- In Vitro Companion Diagnostic Devices - Guidance for Industry and FDA Staff
- Current Good Manufacturing Requirements for Combination Products Final Rule
- Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA (Draft Guidance)
- Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act (Draft Guidance)
- Molecular Diagnostic Instruments with Combined Functions (Draft Guidance)
- FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (Draft Guidance)
- Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling
- Mobile Medical Applications
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De NovoClassifications
- Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft Guidance)
- E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
- Commercially Distributed In VitroDiagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (Draft Guidance)
- Clinical Considerations for Therapeutic Cancer Vaccines
- E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
- Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
- Pharmacogenomic Data Submissions
PRECISION MEDICINE INITIATIVES
PRECISION MEDICINE BIBLIOGRAPHY
