Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Automated support for pharmacovigilance: a proposed system.

Roselie A Bright1, Robert C Nelson

  • 1Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA. rxb@cdrh.fda.gov

Pharmacoepidemiology and Drug Safety
|May 10, 2002
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Finding Potential Adverse Events in the Unstructured Text of Electronic Health Care Records: Development of the Shakespeare Method.

JMIRx med·2023
Same author

Use of Diagnosis Codes to Find Blood Transfusion Adverse Events in Electronic Health Records.

Journal of patient safety·2022
Same author

Extracting chemical reactions from text using Snorkel.

BMC bioinformatics·2020
Same author

2017 Letter From the American Chiropractic Board of Sports Physicians President.

Journal of chiropractic medicine·2018
Same author

Chemical reaction vector embeddings: towards predicting drug metabolism in the human gut microbiome.

Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing·2017
Same author

OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data.

Journal of the American Medical Informatics Association : JAMIA·2015
Same journal

Effectiveness of Metformin in Preventing Colorectal Cancer Among Japanese Patients With Type 2 Diabetes: A Target Trial Emulation.

Pharmacoepidemiology and drug safety·2026
Same journal

Trends in Pharmacist-Prescribed Dispensing Records of HIV Pre-Exposure (2020-2025) and Post-Exposure Prophylaxis (2020-2024) in Brazil: A Time Series Analysis.

Pharmacoepidemiology and drug safety·2026
Same journal

French Consumption of Methylphenidate in Primary Care From 2016 to 2023, Impact of Prescribing Policy Changes-A Time-Series Analysis.

Pharmacoepidemiology and drug safety·2026
Same journal

Uptake and Use of Biologic Therapies in Paediatric Immune-Mediated Inflammatory Diseases: An Australian Population-Based Study.

Pharmacoepidemiology and drug safety·2026
Same journal

Comparative Effectiveness of Oral Fluoropyrimidines Versus FOLFOX as Adjuvant Therapy for Stage III Colon Cancer: A Retrospective Cohort Study Using Overlap-Weighted Restricted Mean Survival Time Analysis.

Pharmacoepidemiology and drug safety·2026
Same journal

Association Between EGFR-TKI-Associated Skin Rash and Recorded Mortality in Non-Small Cell Lung Cancer: A Real-World Analysis Accounting for Immortal Time Bias.

Pharmacoepidemiology and drug safety·2026
See all related articles

The FDA enhanced its medical product safety surveillance by redesigning its adverse event reporting system. This new strategy uses technology to improve the detection and review of potential drug safety signals.

Area of Science:

  • Pharmacovigilance
  • Regulatory Science
  • Health Informatics

Background:

  • Adverse event surveillance is critical for monitoring marketed medical products.
  • Existing surveillance processes required modernization to leverage technological advancements.

Purpose of the Study:

  • To redesign the post-marketing adverse reaction surveillance process at the FDA's Center for Drug Evaluation and Research.
  • To implement a new strategy for reviewing and analyzing adverse event reports efficiently.

Main Methods:

  • Developed a five-tier signal detection strategy for adverse event reports.
  • Incorporated automated review, context matrices, graphical displays, and active query capabilities.
  • Migrated historical data and coded all data using the Medical Dictionary for Regulatory Activities (MedDRA) scheme.

Related Experiment Videos

Main Results:

  • The redesigned system automates initial adverse event review, improving efficiency.
  • Tiered approach allows for immediate attention to urgent reports and comprehensive aggregate review.
  • Active query capabilities enable in-depth exploration of safety signals.

Conclusions:

  • The new strategy enhances the efficiency and effectiveness of clinical assessment of safety signals.
  • Technological integration in adverse event surveillance supports better public health outcomes.
  • The system provides a robust framework for continuous monitoring of medical product safety.