Medical device active surveillance of spontaneous reports: A literature review of signal detection methods

Author:

Chung Gary1ORCID,Etter Katherine1,Yoo Andrew1

Affiliation:

1. Medical Device Epidemiology, Johnson and Johnson Medical Devices New Brunswick New Jersey

Funder

Johnson and Johnson

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference73 articles.

1. Post-Approval Drug Safety Surveillance

2. Why we need observational studies to evaluate the effectiveness of health care

3. External validity of randomised controlled trials: “To whom do the results of this trial apply?”

4. Use of Real‐World Evidence to Support Regulatory Decision‐Making for Medical Devices–Guidance for Industry and Food and Drug Administration Staff.:24.

5. Observational health data sciences and informatics (OHDSI): opportunities for observational researchers;Hripcsak G;Stud Health Technol Inform,2015

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