The field of regulatory affairs deals with the regulatory requirements for marketing
authorization of therapeutic products. This field is facing a myriad of forces impacting all …

Background The aims of this research were to provide a better understanding of the specific
evidence needs for assessment of clinical and cost-effectiveness of cell and gene therapies …

Autoimmune diseases are burdensome conditions that affect a significant fraction of the
global population. The hallmark of autoimmune disease is a host's immune system being …

Access to drugs for rare diseases constitutes a challenge to healthcare systems, especially
those with public funding. This study aimed to map and summarize the criteria used by HTA …

Aim: This paper investigates the conditions for inclusive design of regenerative medicine
interventions from a bioethical perspective, taking regenerative valve implants as a …

The European Medicines Agency (EMA) and European national/regional health technology
assessment (HTA) organizations consider the availability of existing treatments when …

Objectives Advanced therapy medicinal products (ATMPs) are drugs for human use for the
treatment of chronic, degenerative, or life-threatening diseases that are based on genes …

This study proposes a multicriteria analysis to prioritize equipment alternatives for
processing RT-PCR tests to detect the SARS-CoV-2 virus through nasopharyngeal …

ObjectivesThe study, conducted by the French National Authority for Health (HAS), aimed to
identify available online health technology assessment (HTA) training tools for patients …

Introduction Assessing medical technologies for Alzheimer's disease (AD) creates
challenges for current methods of value assessment. New value assessment approaches for …