This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.
Regulatory Policy, Analysis, & Guidance
Reports
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FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
March 31, 2023
Report
Addressing Uncertainty in Regulatory Impact Analysis
October 15, 2021
In 2016, the U.S. Department of Health and Human Services finalized its Guidelines for Regulatory Impact Analysis under the leadership of its Assistant Secretary for Planning Evaluation and Analytics Team. The Guidelines discuss strategies for characterizing the uncertainty in quantified effects as well as the potential impacts of non-quantified effects.
Report
Guidelines for Regulatory Impact Analysis Supplement: Addressing International Effects
October 1, 2021
This report extends the brief discussion of addressing international effects contained in the Department of Health and Human Service Guidelines for Regulatory Impact Analysis (2016). The purpose of this supplement is to expand that discussion and provide more detailed information on conducting such assessments.
Related Products:
Report
Valuing COVID-19 Mortality and Morbidity Risk Reductions in U.S. Department of Health and Human Services Regulatory Impact Analyses
August 20, 2021
This report develops an approach for valuing COVID-19 mortality and morbidity risk reductions based on the U.S. Department of Health and Human Services (HHS) Guidelines for Regulatory Impact Analysis. Valuing risk reductions associated with regulations or other policies that address the novel coronavirus disease 2019 (COVID-19) presents major challenges.
Environmental Scan
State Residential Treatment for Behavioral Health Conditions: Regulation and Policy Environmental Scan
November 26, 2019
The objective of this environmental scan is to summarize the peer-reviewed and grey literature on oversight of residential care for mental health and substance use care in the United States, excluding inpatient hospital care.
Compendium of Residential Care and Assisted Living Regulations and Policy: 2015 Edition - Pennsylvania Profile
June 14, 2015
The purpose of this Compendium is to summarize and compare states’ residential care setting regulations. This is the Pennsylvania state profile. A list of URLs for the full report and other state profiles can be found at the end of this paper.
Compendium of Residential Care and Assisted Living Regulations and Policy: 2015 Edition - Minnesota Profile
June 14, 2015
The purpose of this Compendium is to summarize and compare states’ residential care setting regulations. This is the Minnesota state profile. A list of URLs for the full report and other state profiles can be found at the end of this paper.
Compendium of Residential Care and Assisted Living Regulations and Policy: 2015 Edition - Delaware Profile
June 14, 2015
The purpose of this Compendium is to summarize and compare states’ residential care setting regulations. This is the Delaware state profile. A list of URLs for the full report and other state profiles can be found at the end of this paper.
Compendium of Residential Care and Assisted Living Regulations and Policy: 2015 Edition - South Dakota Profile
June 14, 2015
The purpose of this Compendium is to summarize and compare states’ residential care setting regulations. This is the South Dakota state profile. A list of URLs for the full report and other state profiles can be found at the end of this paper.
Compendium of Residential Care and Assisted Living Regulations and Policy: 2015 Edition - Montana Profile
June 14, 2015
The purpose of this Compendium is to summarize and compare states’ residential care setting regulations. This is the Montana state profile. A list of URLs for the full report and other state profiles can be found at the end of this paper.