Cargando…
Regulatory Flexibilities and Guidances for Addressing the Challenges of COVID-19 in the EU: What Can We Learn from Company Experiences?
The COVID-19 pandemic required urgency in the development and delivery of effective vaccines and therapeutics; meanwhile, ongoing clinical research, regulation and supply for other much-needed therapeutics and vaccines needed to be sustained. In Europe, the European Commission, the European Medicine...
Autores principales: | Klein, Kevin, Stolk, Pieter, Tellner, Pär, Acha, Virginia, Montagne, Sarah, Stöckert, Isabelle |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8821789/ https://www.ncbi.nlm.nih.gov/pubmed/35129827 http://dx.doi.org/10.1007/s43441-022-00383-3 |
Ejemplares similares
-
The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries
por: Klein, Kevin, et al.
Publicado: (2022) -
Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers
por: Klein, Kevin, et al.
Publicado: (2015) -
Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies
por: Nguyen, Diane, et al.
Publicado: (2013) -
Addressing Barriers to Organ Donor Research—A Renewed Call for Regulatory Guidance
por: Glazier, Alexandra K., et al.
Publicado: (2021) -
The FDA guidance for industry on PROs: the point of view of a pharmaceutical company
por: Arpinelli, Fabio, et al.
Publicado: (2006)