FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science-Reference-Cited by-同舟云学术

FDA’s New Guidance for Industry Addressing Evaluation of the Safety of New Drugs for Improving Glycemic Control: A Case Study in Regulatory Science

Published:2020-10-21 Issue:1 Volume:55 Page:1-5
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Rick Turner J.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

https://link.springer.com/content/pdf/10.1007/s43441-020-00211-6.pdf

Reference27 articles.

1. FDA. Guidance for Industry. Type 2 diabetes mellitus: evaluating the safety of new drugs for improving glycemic control. Draft; March 2020. Available at https://www.fda.gov/media/135936/download Accessed 15 April 2020.

2. Turner JR, Karnad DR, Kothari S. Cardiovascular safety in drug development and therapeutic use: new methodologies and evolving regulatory landscapes. Gewerbestrasse: Springer International Publishing; 2017.

3. EMA. Guideline on the clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus. Effective November 2012. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf (Accessed April 17, 2020).

4. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356:2457–71 Epub 2007 May 21.

5. Diamond GA, Bax L, Kaul S. Uncertain effects of rosiglitazone on the risk for myocardial infarction and cardiovascular death. Ann Intern Med. 2007;147:578–81.

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