Search Results for "Poverty Guidelines, Research"
Displaying 1 - 20 of 21 results. 20 results shown per page. Page 1 of 2.
Optimizing Clinical Guidelines to Address Antimicrobial-Resistant Infections: A Conceptual Framework Reflecting Stakeholder Perspectives
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Objectives: Clinical guidelines or guidance is an important tool for preventing and treating antimicrobial-resistant (AMR) infections. We sought to understand and support the effective use of guidelines and guidance for AMR infections.
Inflation Reduction Act Research Series: Understanding Development and Trends in Utilization and Spending for Drugs Selected Under the Medicare Drug Price Negotiation Program
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The Inflation Reduction Act (IRA) authorizes the Secretary of the Department of Health and Human Services (HHS) to negotiate prices directly with participating manufacturers for selected drugs that are high expenditure, single source drugs without generic or biosimilar competition.
HHS Standard Values for Regulatory Analysis
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The U.S. Department of Health and Human Services (HHS) analyzes the benefits, costs, and other impacts of significant proposed and final rulemakings, consistent with the requirements of several executive orders and statutes. HHS develops these analyses according to technical guidance published by the U.S.
Guidelines for Regulatory Impact Analysis Supplement: Addressing International Effects
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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.
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Premarket Notifications and Patents for Breast Pumps Before and After the ACA
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This study investigated whether ACA policies to increase access to breast pumps and lactation care were associated with innovation in the market for breast pumps.
Understanding Markets for Antimicrobial Drugs
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Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
Analysis of Market Challenges for Antimicrobial Drug Development in the United States
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The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.
Antimicrobial Drugs - Burden of Antimicrobial Resistance
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It is well known that antimicrobial resistance (AMR) creates a substantial and ongoing public health and economic burden and understanding the size and nature of this burden is important for the ability to respond to the threat of AMR. However, estimating or projecting that burden within the U.S.
Antimicrobial Drugs - Market Returns Analysis
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In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance.
National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Fiscal Year 2021
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Pathogens that have evolved to be resistant to the drugs currently used to treat infections are an ongoing threat to public health, animal health, food production, and national security. Globally, a recent analysis estimated that 1.2 million deaths were caused by antibiotic-resistant (AR) bacteria in 2019, making this threat a leading cause of death for people of all ages worldwide.
FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
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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.
COVID-19 Vaccine Hesitancy and Reasons for Hesitancy Among Essential and Non-Essential Workers
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Using 2021-2022 survey data from the U.S. Census Bureau’s Household Pulse Survey, this ASPE Research Report examined sociodemographic factors and trends in vaccine hesitancy among workers based on the likelihood of exposure risk to SARS-CoV-2. We classified work setting into three categories: essential healthcare, essential non-healthcare, and non-essential.
Valuing COVID-19 Mortality and Morbidity Risk Reductions in U.S. Department of Health and Human Services Regulatory Impact Analyses
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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.
Addressing Uncertainty in Regulatory Impact Analysis
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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.
Characteristics of Medical Device Shortages in the US, 2006-20
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Shortages of critical medical devices during the COVID-19 pandemic exposed vulnerabilities in device markets. From 2010 to 2019 there were approximately five shortages annually, but that number increased fourfold in the first half of 2020.
Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development
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This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages.
Therapeutic Complex Medical Device Development
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This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.
COVID-19 Vaccination Associated with Reductions in COVID-19 Mortality and Morbidity in the United States, and an Approach to Valuing these Benefits
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This ASPE Research Report models the estimated reductions in COVID-19 cases, hospitalizations, and deaths associated with COVID-19 vaccination from December 2020 through July 2021. To download the Research Report, please download the PDF to the right under “Files”. To explore our dashboard that presents the Report’s results, please see below.
Cost of Generic Drug Development and Approval
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The purpose of this study was to estimate the cost of generic drug development and approval. This study develops an analytical framework for examining the expected net present value (ENPV) (i.e., the difference between the present value of expected revenues over product life and cost of product development and approval) to a generic drug developer in different size drug markets.
Drug Checking Programs in the United States and Internationally: Environmental Scan Summary
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This environmental scan presents a review and synthesis of approaches and strategies adopted by drug checking programs and existing evidence on their effectiveness in changing drug use attitudes, behavior, and health outcomes. It includes studies of drug checking programs across a variety of settings in the United States and internationally.