Real World Evidence: Time for a Switch?-Reference-Cited by-同舟云学术

Real World Evidence: Time for a Switch?

Published:2018-10-09 Issue:12 Volume:41 Page:1309-1312
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Sobel Rachel E.^ORCID,Bate Andrew^ORCID,Reynolds Robert F.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

http://link.springer.com/article/10.1007/s40264-018-0739-y/fulltext.html

Reference19 articles.

1. Ball R, et al. The FDA’s sentinel initiative: a comprehensive approach to medical product surveillance. Clin Pharmacol Ther. 2016;99(3):265–8.

2. US FDA. Prescription Drug User Fee Act Reauthorization (PDUFA VI), Medical Device User Fee Act Reauthorization (MDUFA IV), Generic Drug User Fee Act Reauthorization (GDUFA II), and Biosimilar User Fee Act Reauthorization (BsUFA II). 2017. https://www.fda.gov/NewsEvents/Testimony/ucm547898.htm . Accessed 25 Sep 2018.

3. Gagne JJ, et al. Evaluation of switching patterns in FDA’s Sentinel system: a new tool to assess generic drugs. Drug Saf. 2018. https://doi.org/10.1007/s40264-018-0709-4 (epub 17 Aug 2018).

4. Bohn J, et al. Patterns in spontaneous adverse event reporting among branded and generic antiepileptic drugs. Clin Pharmacol Ther. 2015;97(5):508–17.

5. Barlas S. Frustration over generic drug shortages and prices prompts federal and private actions: health systems take matters into their own hands. Pharmacy Ther. 2018;43(4):211.

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