Regulatory guidelines and preclinical tools to study the biodistribution of RNA therapeutics

Author:

Vervaeke P.,Borgos S.E.,Sanders N.N.,Combes F.

Funder

Research Council of Norway

Research Foundation Flanders

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference175 articles.

1. BioNTech, Project Lightspeed, 2021. https://www.biontech.de.

2. Moderna, Inc., Moderna’s Work on our COVID-19 Vaccine, (n.d.). https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19.

3. First COVID-19 Vaccines Receiving the US FDA and EMA Emergency Use Authorization;Fortner;Discoveries (Craiova).,2021

4. European Medicines Agency, Conditional marketing authorisation, 2018. https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation.

5. Food and Drug Administration, Emergency Use Authorization, 2021. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

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