Are drug safety measures harmonized? A real-world evidence from three regulatory authorities

Author:

Alelayan Sadeem,Al-Sheikh Leena,Almotawa RanaORCID,Alkofide Hadeel,Alshammari ThamirORCID

Publisher

Elsevier BV

Reference20 articles.

1. Comparison of the safety information on drug labels in three developed countries: The USA, UK and Canada;Alshammari;Saudi Pharm J.,2017

2. Pharmacovigilance system in Saudi Arabia;Alshammari;Saudi Pharm. J.,2017

3. Approved Risk Evaluation and Mitigation Strategies (REMS). Accessdata.fda.gov. https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Accessed January 31, 2022.

4. FDA history. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/fda-history. Accessed February 25, 2022.

5. - Grønning N. Data Management in a Regulatory Context. Front Med (Lausanne). 2017;4. doi:10.3389/fmed.2017.004.

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