ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products

Autor: John Hornberger, Tyler J. O’Neill, Ani John, Danelle Miller, Lesley Maloney, Carolyn Hiller, Rebecca A. Miksad
Rok vydání: 2018
Předmět:
medicine.medical_specialty
Process management
media_common.quotation_subject
International Cooperation
Public-Private Sector Partnerships
Risk Assessment
03 medical and health sciences
0302 clinical medicine
Terminology as Topic
medicine
Device Approval
Product Surveillance
Postmarketing
Humans
Regulatory science
Quality (business)
030212 general & internal medicine
Policy Making
Reimbursement
media_common
Government
Evidence-Based Medicine
Equipment Safety
United States Food and Drug Administration
030503 health policy & services
Health Policy
Public Health
Environmental and Occupational Health
Private sector
Health equity
United States
Equipment and Supplies
General partnership
Government Regulation
Interdisciplinary Communication
Business
Patient Safety
Outcomes research
0305 other medical science
Zdroj: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 22(7)
ISSN: 1524-4733
Popis: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) “is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.” In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies. With a focus on regulatory science, the MDIC has been assessing how to apply real-world evidence (RWE) regulatory science to medical devices. A key goal of this project is to review the history of RWE regulatory science, define terms, and explain why and how RWE is being considered across the total product life cycle, including regulatory assessment. Unique considerations of real-world data for in vitro diagnostics are also taken into account. We envision that these activities will help ensure a high level of rigor and integrity of RWE necessary for regulatory use cases and demonstrate where RWE can be successfully used for regulatory decision making. The ISPOR, FDA, and MDIC are providing the needed leadership in ensuring that diverse stakeholders share a meaningful voice in determining RWE use and, by so doing, are improving the quality and efficiency of care, enhancing health outcomes, and addressing broader societal concerns of reducing health disparities and costs.
Databáze: OpenAIRE
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