FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010–2020

Author:

Rathore Anurag S.ORCID,Li Yuexia,Chhabra Hemlata,Lohiya Akshat

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science

Reference43 articles.

1. US Food and Drug Administration. What we do. 2018. https://www.fda.gov/about-fda/what-we-do. Accessed 14 Jun 2021.

2. US Food and Drug Administration. About Warning and Close-Out Letters. 2019. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters. Accessed 10 Jun 2021.

3. US Food and Drug Administration. Regulatory Procedures Manual. Chapter 4 Advisory actions. 2022. https://www.fda.gov/media/71878/download. Accessed 10 Jun 2021.

4. Stewart KA, Neumann PJ. FDA actions against misleading or unsubstantiated economic and quality-of-life promotional claims: An analysis of warning letters and notices of violation. Value Heal. 2002;5(5):390–7.

5. Symonds T, Hackford C, Abraham L. A review of FDA warning letters and notices of violation issued for patient-reported outcomes promotional claims between 2006 and 2012. Value Heal. 2014;17(4):433–7.

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