213,875 research outputs found

    Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA

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    In the United States, the Food and Drug Administration (FDA) agency is responsible for regulating the safety and efficacy of biopharmaceutical drug products. Furthermore, the FDA is tasked with speeding new medical innovations to market. These two missions create an inherent tension within the agency and between the agency and key stakeholders. Oftentimes, communications and interactions between regulated companies and the FDA suffer. The focus of this research is on the interactions between the FDA and the biopharmaceutical companies that perform drug R&D. To assess the current issues and state of communication and interaction between the FDA and industry, we carried out a survey of industry leadership in R&D and regulatory positions as well as senior leadership at the FDA who have responsibility for drug evaluation and oversight. Based on forty-nine industry and eight FDA interviews we conducted, we found that industry seeks additional structured and informal interactions with the FDA, especially during Phase II of development. Overall, industry placed greater value on additional communication than did the FDA. Furthermore, industry interviewees indicated that they were willing to pay PDUFA-like fees during clinical development to ensure that the FDA could hire additional, well-qualified staff to assist with protocol reviews and decision-making. Based on our survey and discussions, we uncovered several thematic opportunities to improve interactions between the FDA and industry and to reduce clinical development times: 1) develop metrics and goals at the FDA for clinical development times in exchange for PDUFA like fees; 2) establish an oversight board consisting of industry, agency officials, and premier external scientists (possibly at NIH or CDC) to evaluate and audit retrospectively completed and terminated drug projects; and 3) construct a knowledge database that can simultaneously protect proprietary data while allowing sponsor companies to understand safety issues and problems of previously developed/failed drug programs. While profound scientific and medical challenges face the FDA and industry, the first step to reducing development times and associated costs and facilitating innovation is to provide an efficient regulatory process that reduces unnecessary uncertainty and delays due to lack of communication and interaction.

    Mapping Land Use Around the San Francisco Bay: A Look at Environmental Justice through S. F. Bay Conservation and Development Commission’s Permitting History

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    Planning and regulatory environmental agency San Francisco Bay Conservation and Development Commission (BCDC) plays an important role in the permitting of development around the San Francisco Bay. As the agency works to add an environmental justice amendment to its primary policy document, this research explores the S.F. Bay Area’s history of approved development project proposal permits, and the associated patterns of land use and environmental justice implications in order to support the proposed change in permitting policy. By classifying all major permits found within BCDC’s internal permit database into groups based on the type of land use associated with the permit project, i.e. Industrial, Flood Control, Ports, etc., it was possible to create maps showing the geographic distribution of each group of permits. To analyze potential environmental justice implications of the patterns of geographic distribution of development permits, each group of permit types was layered on top of spatial data representing areas around the SF Bay that have been identified as highly socially vulnerable. Based on the findings of this project, it appears that highly socially vulnerable communities around the San Francisco Bay bear a disproportionate amount of land-use related environmental burdens. Furthermore, it is crucial to recognize the limitations of geospatial analysis tools in conveying the magnitude of disproportionate environmental and community health impacts of land use on socially vulnerable communities in the San Francisco Bay Area

    Model All-Payer Claims Database Legislation

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    With support from the Gary and Mary West Health Policy Center, the APCD Council has developed model legislation guidance for states to develop all-payer claims database legislation

    Low-Cost Air Quality Monitoring Tools: From Research to Practice (A Workshop Summary).

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    In May 2017, a two-day workshop was held in Los Angeles (California, U.S.A.) to gather practitioners who work with low-cost sensors used to make air quality measurements. The community of practice included individuals from academia, industry, non-profit groups, community-based organizations, and regulatory agencies. The group gathered to share knowledge developed from a variety of pilot projects in hopes of advancing the collective knowledge about how best to use low-cost air quality sensors. Panel discussion topics included: (1) best practices for deployment and calibration of low-cost sensor systems, (2) data standardization efforts and database design, (3) advances in sensor calibration, data management, and data analysis and visualization, and (4) lessons learned from research/community partnerships to encourage purposeful use of sensors and create change/action. Panel discussions summarized knowledge advances and project successes while also highlighting the questions, unresolved issues, and technological limitations that still remain within the low-cost air quality sensor arena
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