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The approval process for new drugs and devices involves submission of data that might not be published elsewhere. These documents can help identify publication bias even when complete methodological details of unpublished trials are unavailable.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a drug’s approval and may be heavily redacted; however, when available, reviewers can compare results of published and unpublished trials.

Regulatory Data - Additional Resources

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