FDA Issues Pharmacoepidemiologic Safety Study Guidance - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Pharmacoepidemiologic Safety Study Guidance


FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies, specifically studies that use electronic healthcare data including administrative claims data and electronic medical record data.

Included in the guidance are recommendations for documenting the design, analysis, and results of pharmacoepidemiologic safety studies to optimize FDA’s review of protocols and final reports that are submitted to the agency. FDA defines a pharmacoepidemiologic safety study in relation to the guidance as “an observational study designed to assess the risk associated with a drug exposure and to test prespecified hypotheses.” The guidance does not address medical devices.

The guidance document provides industry and FDA with direction on designing, conducting, and analyzing pharmacoepidemiologic safety studies. It also creates a framework for industry to use when submitting pharmacoepidemiologic safety-study protocols and final reports to FDA.

FDA states in the guidance document that, although the guidance is not intended to address basic epidemiologic principles, many of the concepts may apply to pharmacoepidemiologic safety studies that use other types of data.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here