Lifecycle of FDA-Regulated Products

As part of its regulatory responsibilities, FDA regulates products at different stages of the lifecycle, depending on the type of product. Regulatory science research is conducted across the phases of the product lifecycle to facilitate product assessment and evaluation, help make better-informed regulatory decisions, and increase the quality, consistency, and safety, or to reduce the associated harms, of FDA-regulated products. For example, if FDA researchers develop an improved understanding of the mechanisms of action of a complex biologic, then this information could augment guidance that FDA provides to product developers on issues such as how to choose critical quality attributes for product characterization, potency assays, and assessment of quality.

FDA researchers also engage in development and evaluation of new methods and models to identify approaches with improved predictive value or that may replace, reduce, and refine (the 3 Rs) the use of animals in research. Current paradigms of clinical evaluation generally result in sometimes costly and time-consuming clinical trials to generate sufficient data to support licensure, approval, or clearance of an FDA-regulated medical product. Therefore, a combination of improved non-clinical evaluation and new ways to perform clinical evaluation may help reduce cost, time, and the risk of developing new and innovative products. Finally, FDA is committed to advancing and protecting the public health through its oversight of FDA-regulated products. To fulfill this commitment, FDA aims to improve the data sources and analytical approaches to support post-market activities. View how the FARS apply to the product lifecycle in the table below.

FDA Strategic Initiative	Focus Area of Regulatory Science	Regulated Product Lifecycle
FDA Strategic Initiative	Focus Area of Regulatory Science	Product Characterization, Manufacturing, and Quality	Non-Clinical Pre-market Evaluation	Clinical Pre-market Evaluation	Post- market Activities
Public Health Preparedness and Response	Medical Countermeasures and Preparedness for Emerging Infectious Diseases	ü	ü	ü	ü
	Technologies to Reduce Pathogen Contamination	ü	ü	ü	ü
	Substance Use Disorders	ü	ü	ü	ü
	Antimicrobial Resistance	ü	ü	ü	ü
	Food Safety	ü	ü		ü
	Quality of Compounded Drugs				ü
Increasing Choice and Competition through Innovation	Individualized Therapies and Precision Medicine	ü	ü	ü	ü
	Complex Innovative Trial Design			ü
	Microbiome Research	ü	ü	ü	ü
	Novel Foods and Food Ingredients	ü	ü	ü	ü
	Regenerative Medicine	ü	ü	ü	ü
	Advanced Manufacturing	ü			ü
	Increasing Access to Complex Generic Drug Products	ü	ü	ü	ü
	Biomarkers	ü	ü	ü	ü
	Novel Technologies to Improve Predictivity of Non-Clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing	ü	ü
	Model-Informed Product Development	ü	ü	ü
Unleashing the Power of Data	Product Safety Surveillance				ü
	Artificial Intelligence	ü	ü	ü	ü
	Digital Health	ü	ü	ü	ü
	Use of Real-World Evidence to Support Medical Product Development and Regulatory Decision-Making			ü	ü
Empowering Patients and Consumers	Patient and Consumer Preferences and Perspectives	ü	ü	ü	ü
	Patient-Reported Outcomes and other Clinical Outcome Assessments			ü	ü
	Empowering Patients and Consumers to Make Better-Informed Decisions				ü

CROSS-CUTTING TOPICS

Minority Health and Health Equity	Women’s Health	Maternal Health	Pediatric Health
Oncology	Rare Diseases	One Health Initiative

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing	Antimicrobial Resistance	Artificial Intelligence	Biomarkers
Complex Innovative Trial Design	Digital Health Technologies	Empowering Patients and Consumers to Make Better-Informed Decisions	Food Safety
Increasing Access to Complex Generic Drug Products	Individualized Therapeutics and Precision Medicine	Medical Countermeasures and Preparedness for Emerging Infectious Diseases	Microbiome Research
Model-Informed Product Development	Novel Foods and Food Ingredients	Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing	Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments	Product Safety Surveillance	Quality of Compounded Drugs	Regenerative Medicine
	Substance Use Disorders	Technologies to Reduce Pathogen Contamination	Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

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Scientific Education, Training, and Communication

Infrastructure