Department of Neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: xuwh@pumch.cn.
Department of Radiology and Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, 567 Baekje-daero, deokjin-gu, Jeonju-si, Jeollabuk-do, 561-756, Republic of Korea. kwak8140@jbnu.ac.kr.
Department of Radiology and Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, 567 Baekje-daero, deokjin-gu, Jeonju-si, Jeollabuk-do, 561-756, Republic of Korea.
Department of Neurosurgery and Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu 215006, P.R. China.
Anatomy and Neuroscience (JC), School of Biomedical Sciences, University of Melbourne, Parkville; Department of Surgery (JC), Alfred Hospital, Melbourne, Victoria; Interventional Radiology Service (JM, MB, HA), Department of Radiology, Austin Hospital, Melbourne; School of Medicine (JM, MB, HA), Faculty of Health, Deakin University, Waurn Ponds; Stroke Division (JM, MB, HA), Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria; Interventional Neuroradiology Service (HA), Department of Radiology, St Vincent's Hospital; Interventional Neuroradiology Unit (RVC, L-AS, HA), Monash Imaging, Monash Health; and Faculty of Medicine (RVC, HA), Nursing and Health Sciences, Monash University, Melbourne, Australia.
Anatomy and Neuroscience (JC), School of Biomedical Sciences, University of Melbourne, Parkville; Department of Surgery (JC), Alfred Hospital, Melbourne, Victoria; Interventional Radiology Service (JM, MB, HA), Department of Radiology, Austin Hospital, Melbourne; School of Medicine (JM, MB, HA), Faculty of Health, Deakin University, Waurn Ponds; Stroke Division (JM, MB, HA), Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria; Interventional Neuroradiology Service (HA), Department of Radiology, St Vincent's Hospital; Interventional Neuroradiology Unit (RVC, L-AS, HA), Monash Imaging, Monash Health; and Faculty of Medicine (RVC, HA), Nursing and Health Sciences, Monash University, Melbourne, Australia.
THIS REPORT SUMMARIZES ALL RECOMMENDATIONS FROM CDC'S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) FOR THE USE OF LYOPHILIZED CVD 103-HGR VACCINE (CVD 103-HGR) (VAXCHORA, EMERGENT BIOSOLUTIONS,...
During premarket review, the US Food and Drug Administration may ask its Medical Device Advisory Committee (MDAC) Panels to assess the safety and effectiveness of medical devices being considered for ...
This was a retrospective cohort study of routinely collected data from voting members of MDAC panels convened between January 2011 to June 2016 to consider premarket approval. Data sources were verbat...
658,954 words spoken by 536 members during 49 meetings of 11 Panels were analyzed. Based on multivariate analysis, biostatisticians spoke more (+373 words; P = 0.0002), and women (-187 words; P = 0.01...
Panelists likely to vote against the majority include non-physician, non-biostatisticians; experienced Panelists; and more talkative members. The increased presence of biostatisticians on Panels leads...
Continuing Professional Development (CPD) has received increased attention within the pharmacy profession in the United States and is recognized as a potential pathway for ongoing professional develop...
The COVID-19 pandemic has challenged traditional vaccine guidance infrastructure and frameworks, and added urgency and complexity to the operation of National Immunization Technical Advisory Groups (N...
Judgments and integrity uphold professionalism. Failure to manage professional conflicts of interest (COIs) may undermine trust in an individual, practitioner, or institution. This perspective article...
The purpose of this project was to gain insight into the role of patient-reported outcome (PRO) data in US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) reviews and reco...
ODAC meeting transcripts were reviewed for any mention of PRO-related concepts. Meetings that reviewed biosimilars and meetings that discussed conceptual matters were excluded. For each identified tra...
Twenty-seven transcripts of reviews were identified for 2016-2021. Topics related to PROs were included in 12 of those 27 reviews. The ODAC was satisfied with PROs included in 2 of those 12 reviews. R...
Less than half of ODAC reviews in 2016-2021 included PROs, and reviewers expressed frustration at the lack of PRO data. Even when included, evidence on the basis of PROs was rarely deemed adequate for...
A range of community engagement initiatives to advance health and wellbeing are currently taking place in informal settlements in low and middle income countries (LMICs), including community and stake...
In this paper, using in-depth interviews, we document the roles of CACs in advancing health and wellbeing in Korogocho and Viwandani informal settlements in Nairobi, Kenya....
Study participants described the role of CAC in advancing health and wellbeing through education and awareness creation, advisory roles in research and implementation goals, protecting community inter...
We conclude that CACs play key roles in advancing health and wellbeing in informal settlements and that existing CACs mechanisms and operations need to be given due consideration by researchers, proje...
Introduction The Cancer Health Assessments Reaching Many study seeks to reduce disparities in genomic care. Two patient advisory committees (PACs) were formed, 1 of English speakers and 1 of Spanish s...
Vaccination is the main means for preventing measles, mumps, and rubella virus infections and their related complications (1,2). Achieving and maintaining high 2-dose measles, mumps, and rubella vacci...
The US Food and Drug Administration (FDA) often relies on independent advisory committees when making decisions about the approval of prescription drugs or their withdrawal from the market. These comm...
To assess the frequency, purposes, and voting outcomes of human drug advisory committees convened from 2010 to 2021 and the FDA's corresponding actions....
This qualitative study used a manual review of meeting summaries prepared by FDA staff for the 18 human drug advisory committees active at any time from January 1, 2010, to December 31, 2021, as well ...
Outcomes of votes on regulatory questions were recorded using meeting minutes. Alignment of FDA action with advisory votes for new drugs and indications was judged as of 1 year after the vote was held...
The FDA held 409 human drug advisory committee meetings from 2010 to 2021. Committees were convened less frequently over time, from a high of 50 in 2012 to a low of 18 in 2020 and 2021. Much of this d...
In this qualitative study, there was consistent alignment between advisory votes and FDA action across years and subject areas, but the number of meetings decreased over time. Discordance between FDA ...
