FDA in Brief: FDA’s 2019 Science Forum highlights latest regulatory science in emerging technologies and leading public health challenges

FDA in Brief: FDA’s 2019 Science Forum highlights latest regulatory science in emerging technologies and leading public health challenges 

The U.S. Food and Drug Administration is holding the 2019 FDA Science Forum, ”Transforming Health: Innovation in FDA Science,” on the agency’s White Oak campus on Sept. 11, 2019, from 8:30 a.m. - 4:45 p.m. and Sept. 12, 2019, from 9 a.m. - 4 p.m. The two-day event will showcase the collaborative efforts of FDA’s scientists as well as nationally renowned scientists from outside the agency.

Highlights from key topic areas include: Precision Health: Presenting a novel proposed regulatory framework for digital health, the potential for genomic biomarker use in cardiovascular disease trials, and research on sex differences during drug development. Advanced Technologies: The latest on methods, tools, materials, and products used either to make or evaluate products FDA regulates, such as genome editing or sequencing (in food safety), predictive tools for toxicity and efficacy, and modeling and simulation for medical devices. Product Accessibility, Integrity, and Security: Strategies for protecting the U.S. food system against attack; an advanced, risk-based method for screening imported food shipments for security and safety; strategies for preventing and mitigating biological product shortages. Advancing Digital Health and Artificial Intelligence: The potential impact of artificial intelligence in medical devices; using computers for modeling and simulation of phenomena relevant to the FDA’s mission, e.g. analyzing large data sets; collecting and assessing real-world evidence, such as understanding and harnessing artificial intelligence and evaluating digital health devices; using large datasets for predictive modeling of polypharmacy issues.

Novel approaches to emerging disease threats or foodborne outbreaks: The FDA’s approach to preventing and responding to infectious disease and foodborne pathogen outbreaks, including the use of the animal rule, emergency communication devices, rapid diagnostic tests, anti-microbial resistance, and protecting people from emerging infectious disease threats. Addiction: Overview of drug abuse and addiction in the U.S.; chemical and in vivo strategies for determining potency and efficacy of novel synthetic opioids in the rat model; FDA assessment of the abuse potential of central nervous system-acting drugs; chemistry, biology, user behavior and exposure, social science and marketing, modeling, and prescribing behavior.

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