@article{4ecb38ceb8e74f03bc82ecd2666ad04a,
title = "Time to Revisit a Voluntary FDA Comparative Effectiveness Pathway",
abstract = "Given the renewed policy focus on drug pricing and pharmaceutical innovation, this article examines the historical backdrop of efforts to integrate comparative effectiveness research into the FDA drug review process. Noting previous policy efforts over a decade ago, we characterize industry challenges and suggest a path forward.",
keywords = "Comparative effectiveness research, FDA regulation, Innovation, Real world evidence",
author = "Miller, {Brian J.} and Vrushab Gowda and Segal, {Jodi B.}",
note = "Funding Information: Vrushab Gowda reports receiving fees outside the related work from Legacy, a fertility preservation start-up. Dr. Miller reports serving as a member of the CMS Medicare Evidence Development and Coverage Advisory Committee, and receiving fees outside the related work from the Federal Trade Commission, the Health Resources and Services Administration, Oxidien Pharmaceuticals, and the Heritage Foundation. Dr. Segal reports grant support outside the related work from the National Institutes of Health, the Arnold Foundation, and the U.S. Food and Drug Administration, and receiving fees outside the related work from 3D Communications, Altarum, and the American College of Physicians. Publisher Copyright: {\textcopyright} 2021, The Drug Information Association, Inc.",
year = "2021",
month = jul,
doi = "10.1007/s43441-021-00261-4",
language = "English (US)",
volume = "55",
pages = "643--645",
journal = "Therapeutic Innovation and Regulatory Science",
issn = "2168-4790",
publisher = "SAGE Publications Inc.",
number = "4",
}