Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database-Reference-Cited by-同舟云学术

Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database

Published:2018-05-03 Issue:2 Volume:5 Page:117-128
ISSN:2199-1154
Container-title:Drugs - Real World Outcomes
language:en
Short-container-title:Drugs - Real World Outcomes

Author:

Toki Tadashi,Ono Shunsuke^ORCID

Funder

The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Link

http://link.springer.com/article/10.1007/s40801-018-0134-0/fulltext.html

Reference43 articles.

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3. Minister of Health, Labour and Welfare. Strategy of SAKIGAKE. 2017. http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html . Accessed 14 Nov 2017.

4. Kwok M, Foster T, Steinberg M. Expedited programs for serious conditions: an update on breakthrough therapy designation. Clin Ther. 2015;37(9):2104–20.

5. Mostaghim SR, Gagne JJ, Kesselheim AS. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017;358:j3837.

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