A review on the evolving environment of medical device real-world evidence regulation on market access in the USA.

Cost Eff Resour Alloc

UNESCO-The World Academy of Sciences TWAS, Trieste, 34100, Italy.

Published: October 2024

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11515808PMC
http://dx.doi.org/10.1186/s12962-024-00582-9DOI Listing

Publication Analysis

Top Keywords

review evolving
4
evolving environment
4
environment medical
4
medical device
4
device real-world
4
real-world evidence
4
evidence regulation
4
regulation market
4
market access
4
access usa
4

Similar Publications

Epstein-Barr virus (EBV) and Kaposi's sarcoma-associated herpesvirus (KSHV), which are the only members of the gamma(γ) herpesviruses, are oncogenic viruses that significantly contribute to the development of various human cancers, such as Burkitt's lymphoma, nasopharyngeal carcinoma, Hodgkin's lymphoma, Kaposi's sarcoma, and primary effusion lymphoma. Oncogenesis triggered by γ-herpesviruses involves complex interactions between viral genetics, host cellular mechanisms, and immune evasion strategies. At the genetic level, crucial viral oncogenes participate in the disruption of cell signaling, leading to uncontrolled proliferation and inhibition of apoptosis.

View Article and Find Full Text PDF

Rewriting Viral Fate: Epigenetic and Transcriptional Dynamics in KSHV Infection.

Viruses

November 2024

State Key Laboratory of Virology, College of Life Sciences, Wuhan University, Wuhan 430072, China.

Kaposi's sarcoma-associated herpesvirus (KSHV), a γ-herpesvirus, is predominantly associated with Kaposi's sarcoma (KS) as well as two lymphoproliferative disorders: primary effusion lymphoma (PEL) and multicentric Castleman disease (MCD). Like other herpesviruses, KSHV employs two distinct life cycles: latency and lytic replication. To establish a lifelong persistent infection, KSHV has evolved various strategies to manipulate the epigenetic machinery of the host.

View Article and Find Full Text PDF

This report examines the evolving role of coronavirus disease 2019 (COVID-19) vaccination in Japan, especially in light of the reduced public concern following the reclassification of COVID-19 as a Category 5 infectious disease in May 2023. With over half the population estimated to have hybrid immunity from prior infections and vaccinations, this report evaluated the necessity and frequency of additional booster doses. Despite strong recommendations from Japanese medical societies to continue vaccination, public skepticism remains owing to financial burdens, adverse reactions, and the perceived limited benefits of frequent boosters.

View Article and Find Full Text PDF

The Strategic Advisory Group of Experts (SAGE) on Immunization-Past, Present and Future.

Vaccines (Basel)

December 2024

Department of Immunization, Vaccines and Biologicals, World Health Organization, CH-1211 Geneva, Switzerland.

Background/objectives: In November 1999, WHO established the Strategic Advisory Group of Experts (SAGE) on Immunization as a multidisciplinary group of experts to provide high-level recommendations on vaccines and immunization.

Methods: This review provides an overview of SAGE's work in the past 25 years. It further outlines the processes and methods currently used by SAGE and highlights some of its major achievements.

View Article and Find Full Text PDF

Influenza poses a significant global health challenge due to its rapid mutation and antigenic variability, which often leads to seasonal epidemics and frequent outbreaks. Traditional vaccines struggle to offer comprehensive protection because of mismatches with circulating viral strains. The development of a broad-spectrum vaccine is therefore crucial.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!