9/19 Workshop #2: Discuss Methodologic & Other Challenges Related to Patient Experience Data- Part 1
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On September 18th and 19th 2025, FDA hosted a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other areas of greatest interest or concern to public stakeholders. This workshop featured presentations and panel discussions with experts on selected methodologies and the challenges and opportunities they present. In addition, this workshop presented a draft version of an updated evidence dossier template to facilitate the submissions of evidence to FDA to support a Clinical Outcome Assessment.
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NIH deputy director Lawrence Tabak admitted to Congress that the NIH funded gain-of-function research at the Wuhan Institute of Virology. This admission follows years of evasive answers from federal health officials, including Dr. Anthony Fauci, about funding such controversial research. In response to these issues, the US Department of Health and Human Services recently barred the Wuhan Institute from receiving federal grants for ten years and pulled all funding from EcoHealth Alliance for three years. Fauci is scheduled to answer questions about the gain-of-function research at the Wuhan lab and theories of the origin of the pandemic in a public subcommittee hearing set for June 3.” That should be an interesting conversation. - More info: https://www.drtrozzi.news/p/wins-of-the-week-ep22-with-ted-kuntz
