BackgroundThe U.S. Food and Drug Administration (FDA) traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation.
Africa, Biodiversity, Community-based conservation, Community ecology, Ecosystem services, Diversity, Ecotourism, Stability, Wildlife,
The US Food and Drug Administration (FDA) has been the standard of drug regulation worldwide for decades. In 1962, in response to the thalidomide tragedy, Congress directed the FDA to evaluate the effectiveness of drugs based on "adequate and well-controlled investigations, including clinical investigations" conducted by qualified experts.Backed by this congressional enactment, the FDA crafted groundbreaking administrative regulations (eg, the requirements of a prespecified protocol, placebo or active controls, the phasing of clinical investigations, and informed consent from patients) that have guided the global clinical trial enterprise ever since. 1 The FDA's regulations revolutionized the evaluation of drugs in the United States and abroad.However, the European Medicines Agency (EMA), the counterpart to the FDA in the European Union, is poised to leapfrog ahead of the FDA in an equally important drug regulatory space of transparency. In October 2016, the EMA published on its website the clinical study reports for 2 drugs (carfilzomib and lesinurad) it recently approved. In so doing, the EMA VIEWPOINT
Objective: To identify predictors of unmet dental needs for adults 18 y of age or older in the United States. Method: Using the Aday and Andersen framework and data from the 2018 Behavioral Risk Factor Surveillance System (BRFSS), we ran logistic regression to estimate predictors for adults of not having a dental visit within 5 y and having lost any teeth using a national sample of 155,060 survey respondents. Results: Results showed that predisposing factors (age, race/ethnicity, gender, and educational attainment) and enabling factors (income and health insurance status) are important predictors for losing teeth due to decay or gum disease. Men, the elderly, and less educated and low-income residents were less likely to have seen a dentist within the past 5 y and more likely to have lost their permanent teeth. Compared to non-Hispanic White adults, Hispanics adults were more likely to have had a dental visit within the past 5 y. Unmet dental needs varied across states. People living in states with extensive Medicaid dental care benefit coverage were less likely to lose their teeth and more likely to have had a dental visit within the past 5 y. Conclusion: Efforts to improve oral health should address unmet dental needs of men and adults with low socioeconomic status. Studying the variation between state oral health care programs could further our understanding of how public policy can improve population oral health. Knowledge Transfer Statement: Men, non-Hispanic Blacks, mixed and other race minorities, and low socioeconomic status adults are most at risk of unmet dental needs. States can address these needs by expanding Medicaid coverage for adults.
Objectives To learn dentists' perceptions, attitudes, and concerns about the problems of access to oral health care for low income and rural Marylanders and to ascertain whether the dentists believe dental therapy is a viable solution. Methods We conducted three focus group discussions of 27 dentists during August and September 2018 in three locations in urban and rural areas of Maryland. Results Focus group participants felt that problems with access to dental care for low income and rural Marylander were not due to a shortage of dental providers. They believed there are more than enough dentists in the state. Access problems in Maryland are due in large part to inadequate insurance coverage and low oral health literacy. With the exception of one participant, the dentists would not use dental therapists in their practices to expand access. Conclusions Maryland dentists in our focus group strongly oppose the use of dental therapists to address the state's unmet oral health care needs. Any effort to expand the state's dental workforce using dental therapists must address Maryland dentists' concerns and opinions.
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