LibGuides: Resources for Grey Literature: Regulatory Info

Regulatory Data - Primary Resources

The approval process for new drugs and devices involves submission of data that might not be published elsewhere. These documents can help identify publication bias even when complete methodological details of unpublished trials are unavailable. This information is not available prior to a drug’s approval and may be heavily redacted; however, when available, reviewers can compare results of published and unpublished trials.

Drugs@FDA
Presented by the US Food and Drug Administration (FDA), this site can be searched by drug name or active ingredient. Select an individual drug to view “Approval History, Letters, Reviews, and Related Documents.” Trial data are usually found in the Reviews.
Devices@FDA
This FDA site includes information about approved medical devices. It contains documents regarding approval, summary of safety and effectiveness, and relevant clinical trials, from 1995 to the present.
Health Canada Drug Product Database (DPD)
The DPD contains product-specific information on drugs approved for use in Canada. Entries may link to a drug monograph containing summary information and trial information.
European Public Assessment Reports
The European Medicines Agency publishes a full scientific assessment report called a European public assessment report (EPAR) for every medicine granted a central marketing authorisation by the European Commission.

Regulatory Data - Additional Resources

If further information is requested, these are additional resources to consider:

FDA: Dockets Management
This website serves as the official repository for the administrative proceedings and rule-making documents for the FDA. It also provides presentations, usually in PowerPoint format, and background information on clinical trials. Transcripts may include discussion of unpublished data that was presented during hearings.
FDA: MedWatch
The FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Drug Information Portal
From the National Library of Medicine