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As part of its mission to protect public health and promote innovation, FDA helps medical product developers translate discoveries in basic science into safe and effective new therapies that save lives and improve health care.

One important way that FDA does this is by advancing the tools, methods, and models used to develop medical products, which reduces the time, complexity, and cost of their development, while maintaining patient protections. This effort enables patients’ faster access to life-improving and life-saving medicines, biologics, and devices.

FDA culled the following resources from across its web site, which can be leveraged to further the use of these tools in medical product development.

All Medical ProductsDrugsMedical DevicesDraft and Final Guidances

All Medical Products

Personalized Medicine
	Biomarkers at FDA
	**BEST (Biomarkers, Endpoints, and other Tools) Resource**. This resource was developed by an NIH-FDA joint team in response to a need to harmonize terms used in translational science and medical product development. The first phase of BEST comprises a glossary that clarifies important definitions and describes some of the hierarchical relationships, connections and dependencies among the terms it contains. NIH and FDA intend to use the definitions included in this glossary when communicating on topics related to its contents (e.g. biomarkers) to ensure a consistent use of the terms and therefore, a common understanding of the issues.
	BEST Resource Fact SheetDrugs

Drug Development Tools (DDT) Qualification Programs

	Animal Model Qualification Program
		Biomarker Qualification Program
		Clinical Outcome Assessment Qualification Program
	GenomicsMedical Devices

In Vitro Diagnostics
	Laboratory Developed Tests
	Companion Diagnostics
	Medical Device Development Tools (MDDT)Draft and Final Guidances*

Year
			Title
			FDA Medical Product Centers2009
			Guidance for Industry:Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
			CBER
			CDER
			CDRH2010
			Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics
			CBER
			CDER2010
			Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies- Frequently Asked Questions
			CBER
			CDRH2011
			Guidance for Industry: Use of Histology in Biomarker Qualification Studies
			CDER2011
			Guidance for Industry: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
			CBER
			CDER2012
			Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
			CBER
			CDER
			CDRH2014
			Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools
			CDER2014
			Guidance for Industry and FDA Staff: In Vitro Companion Diagnostic Devices
			CBER
			CDER
			CDRH2015
			Guidance for Industry: Product Development Under the Animal Rule
			CBER
			CDER

* Note: this is not an all-inclusive list of FDA guidance documents on this topic. Additional guidance documents can be found using the guidance document search.

                                                                                  Content current as of:
      02/13/2018
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesTopic(s)
			  Drug Development ToolsAbout Science & Research at FDA

          
                        Emerging Sciences
          Public Access to Results of FDA-Funded Scientific Research
          Scientific Integrity at FDA
          FDA Sexual Harassment Policy Concerning Extramural Research
          Medical Product Development Tools at FDA
          Modeling & Simulation
          FDA's Predictive Toxicology Roadmap


                        Advancing Alternative Methods at FDA
          FDA Grand Rounds
          The FDA Science Forum
 
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