Transitions, Introductions, and a Notable Announcement From the US FDA in December 2016-Reference-Cited by-同舟云学术

Transitions, Introductions, and a Notable Announcement From the US FDA in December 2016

Published:2017-03 Issue:2 Volume:51 Page:140-141
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Turner J. Rick

Publisher

Springer Science and Business Media LLC

Subject

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

Link

http://link.springer.com/content/pdf/10.1177/2168479017691939.pdf

Reference14 articles.

1. FDA News Release, December 2, 2016. FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm531517.htm. Accessed January 2, 2017.

2. FDA News Release, August 1, 2014. FDA approves Jardiance to treat type 2 diabetes. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407637.htm. Accessed January 2, 2017.

3. Meigs JB. Epidemiology of cardiovascular complications in type 2 diabetes. Acta Diabetol. 2003;40:S358–S361.

4. FDA. Guidance for Industry. Diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf. Published December 2008. Accessed January 2, 2017.

5. Geiger MJ, Mehta C, Turner JR, et al. Clinical development approaches and statistical methodologies to prospectively assess the cardiovascular risk of new antidiabetic therapies for type 2 diabetes. Ther Innov Regul Sci. 2015;49:50–64.

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