Costs of Overly Broad Recalls.

Overly broad recalls following an FDA advisory occur when the source of an outbreak is originally misidentified or cannot be promptly identified. In this situation, an entire product category might be recalled (e.g.

Costs of Drug Development and Research and Development Intensity in the US, 2000-2018.

Importance: Understanding the cost of drug development can help inform the development of policies to reduce costs, encourage innovation, and improve patient access to drugs.

Objective: To estimate the cost of drug development by therapeutic class and trends in pharmaceutical research and development (R&D) intensity over time.

Design, Setting, And Participants: In this economic evaluation study, an analytical model of drug development constructed using public and proprietary sources that collectively cover data from 2000 to 2018 was used to estimate the cost of bringing a drug to market, overall and for specific therapeutic classes.

Assessing the state of antibacterial drug discovery through patent analysis.

Patent filings suggest increasing intensity of antibacterial drug discovery in recent years, but the share of patents published by commercial companies has declined.

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US.

Importance: The US medical device market is the world's largest, but estimates of the cost to bring a medical device to market are not available to help inform policy making and regulatory efforts to enhance device safety and innovation.

Objective: To estimate the mean expected capitalized cost of developing a novel therapeutic complex medical device.

Design, Setting, And Participants: In this economic evaluation, an analytical model of novel therapeutic complex medical device development using data from public and proprietary sources with coverage from 2000 through 2018 was used to estimate the cost, duration, and phase transition success probability associated with each stage of development.

The Use of Expert Elicitation among Computational Modeling Studies in Health Research: A Systematic Review.

Background: Expert elicitation (EE) has been used across disciplines to estimate input parameters for computational modeling research when information is sparse or conflictual.

Objectives: We conducted a systematic review to compare EE methods used to generate model input parameters in health research.

Data Sources: PubMed and Web of Science.

An Expert Elicitation on the Effects of a Ban on Menthol Cigarettes and Cigars in the United States.

Introduction: The US Food and Drug Administration announced its intention to ban menthol in cigarettes. However, information is needed on how a federal ban would affect population health.

Aims And Methods: We conducted an expert elicitation to gauge the impact of a menthol cigarette and cigar ban in the United States.

Societal willingness to pay to avoid mortality and morbidity from Clostridioides difficile and carbapenem-resistant Enterobacteriaceae infections in the United States.

Background: Clostridioides difficile infection (CDI) is among the most common health care-associated infections in the United States and is increasingly affecting the elderly. Although carbapenem-resistant Enterobacteriaceae (CRE) infections are still relatively uncommon, there are reported increases in the rate of infection for certain strains, such as Klebsiella pneumoniae. This study examines the burden of mortality and morbidity for CDI and CRE infections in the United States and estimates the societal willingness to pay to avoid them.

Promoting Antibacterial Drug Development: Select Policies and Challenges.

Background: The development pipeline for antibacterial drugs has not met the demand of hospitals and healthcare providers struggling to cope with increasing problems of antibacterial resistance. Although the challenges associated with antibacterial drug development have been known for some time, previous efforts to address them have not been sufficient. There remains an urgent need for targeted incentives to foster antibacterial drug development while encouraging prudent use.

Key cost drivers of pharmaceutical clinical trials in the United States.

Background: The increasing cost of clinical research has significant implications for public health, as it affects drug companies' willingness to undertake clinical trials, which in turn limits patient access to novel treatments. Thus, gaining a better understanding of the key cost drivers of clinical research in the United States is important.

Purpose: The study which is based on a report prepared by Eastern Research Group, Inc.