Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?-Reference-Cited by-同舟云学术

Assessing strength of evidence for regulatory decision making in licensing: What proof do we need for observational studies of effectiveness?

Published:2020-04-16 Issue:10 Volume:29 Page:1336-1340
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Slattery Jim¹^ORCID,Kurz Xavier¹^ORCID

Affiliation:

1. European Medicines Agency Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5005

Reference19 articles.

1. Examining the Use of Real‐World Evidence in the Regulatory Process

2. IX. On the problem of the most efficient tests of statistical hypotheses

3. Accessdata.fda.gov. CFR—Code of Federal Regulations Title 21 [online];2020. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=314.126. Accessed February 24 2020.

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