A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the <scp>US</scp> and <scp>EU</scp>-Reference-Cited by-同舟云学术

A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU

Published:2022-05-31 Issue:8 Volume:15 Page:1959-1967
ISSN:1752-8054
Container-title:Clinical and Translational Science
language:en
Short-container-title:Clinical Translational Sci

Author:

da Costa Gonçalves Fabiany¹^ORCID,Demirci Ebru¹,Zwiers Alex¹^ORCID

Affiliation:

1. Zwiers Regulatory Consultancy Oss The Netherlands

Publisher

Wiley

Subject

General Pharmacology, Toxicology and Pharmaceutics,General Biochemistry, Genetics and Molecular Biology,General Medicine,General Neuroscience

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/cts.13308

Reference18 articles.

1. Unequal Access to Newly Registered Cancer Drugs Leads to Potential Loss of Life-Years in Europe

2. Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval

3. US Food and Drug Administration.Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics;2019. Accessed September 27 2021.https://www.fda.gov/media/86377/download

4. FDA Website.Regenerative Medicine Advanced Therapy. Accessed September 27 2021.https://www.fda.gov/vaccines‐blood‐biologics/cellular‐gene‐therapy‐products/regenerative‐medicine‐advanced‐therapy‐designation

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