News from Friday, February 20, 2026
Articles
FDA Plans Formal Launch Of ‘Plausible Mechanism’ Guidance
(2/19, Maaisha Osman, Inside Health Policy) reports “FDA will formally launch its ‘plausible mechanism’ pathway aimed at accelerating development and approval of highly personalized therapies for rare and ultra-rare diseases Monday (Feb. 23) with the release of long-awaiting draft guidance and an event at HHS headquarters...Under the plausible mechanism pathway, FDA will approve products targeting specific, well-understood genetic abnormalities -- not diseases defined by broad clinical syndromes or uncertain genetic associations.” Subscription Required
AHA, Others Urge HRSA to Extend Comment Deadline on 340B Rebate Program
(2/19, American Hospital Association) comments "...Specifically, the groups urged HRSA to extend the comment deadline to April 20 to give stakeholders sufficient time to gather information and provide complete answers to dozens of detailed questions contained in the RFI. The current deadline for comments is March 19. 'In general, this timeline would better allow stakeholders, including the 340B hospital field, to provide the agency with meaningful feedback,' the groups wrote." Full
Press Releases
Interoperable Data Systems Can Improve Cancer Care
(2/19, Regenstrief Institute Press Release) “...‘In a Learning Health System, we use information from electronic health records, clinical outcomes and patient experiences to continuously analyze what works best. That allows care teams to learn from every patient encounter and use those insights to improve treatment decisions and overall quality of care,’ said Christina M. Scifres, M.D., Leader, Regenstrief Institute Strategic Initiative on Learning Health Systems.” Full
Journals
Modernizing Data and Data Science Infrastructure as a Strategic Asset for Cancer Center
Yi Guo, et al.
January 9, 2026, NPJ Health Systems
Reframing Population-Adjusted Indirect Comparisons as a Transportability Problem: An Estimand-Based Perspective and Implications for Health Technology Assessment
Conor Chandler, et al.
February 19, 2026, arXiv
Characteristics of the Long-Term Care Data Cooperative: A New Resource for Research on Outcomes in Long-Term Care
Stephanie M Kissam, et al.
February 19, 2026, Journal of the American Geriatrics Society