What Should Be Clinicians' Roles in Regulatory Assessment of Prospective Interventions' Risks of Exacerbating Inequity?
Sign Up to like & getrecommendations! Published in 2023 at "AMA journal of ethics"
DOI: 10.1001/amajethics.2023.204
Abstract: When there is an evidence base that could be used credibly to justify expedited US Food and Drug Administration review, emergency use authorization, or approval, interventions-in-development must be evaluated in terms of their possible downstream… read more here.
Keywords: inequity; prospective interventions; roles regulatory; regulatory assessment ... See more keywords
Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health-an EFPIA View.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical therapeutics"
DOI: 10.1016/j.clinthera.2021.11.001
Abstract: The European Union regulatory framework supports development, review, authorization, and maintenance of medicines to benefit public health; however, many elements are 2 decades old and undergoing review. Scrutiny was triggered by the coronavirus disease 2019… read more here.
Keywords: assessment; regulatory framework; dynamic regulatory; public health ... See more keywords