Regulatory Policy, Analysis, & Guidance

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.

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.

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:

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.

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.

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.

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.

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.

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.

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.