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Drug/Biologic |
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The Pre-Submission Program and Meetings with FDA Staff - Draft Guidance-July 13, 2012 |
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling - Draft Guidance-January 28, 2013 |
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Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review - Draft Guidance-August 15, 2011 |
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products - Draft Guidance-December 17, 2012 |
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Design Considerations for Pivotal Clinical Investigations for Medical Devices - Draft Guidance-August 15, 2011 |
Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval - Draft Guidance-May 21, 2012 |
510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device - Withdrawn in accordance with the Food and Drug Administration Safety and Innovation Act July 17, 2012-Originally issued July 27, 2011
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E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions - Final Guidance-August 2011 |
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Mobile Medical Applications - Draft Guidance-July 21, 2011 |
Qualification Process for Drug Development Tools - Draft Guidance-October 2010 |
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In Vitro Companion Diagnostic Devices Draft Guidance-July 14, 2011 |
Adaptive Design Clinical Trials for Drugs and Biologics - Draft Guidance-February-2010 |
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Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions - Draft Guidance-June 1, 2011 |
E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories Final Guidance-April 2008 |
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Pharmacogenetic Tests and Genetic Tests for Heritable Marker - Final Guidance-June 19, 2007 |
Pharmacogenomic Data Submissions — Companion Guidance - Draft Guidance-August 24, 2007 |
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Guiding Principles for Joint FDA EMEA Voluntary Genomic Data Submission Briefing Meetings - Final Guidance-May 19, 2006 |
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Processing and Reviewing Voluntary Genomic Data Submissions (VGDSs) Final Guidance-March 16, 2005 |
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Pharmacogenomic Data Submissions Final Guidance-March 2005 |
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