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Post-Marketing Surveillance Programs
Post-Marketing Surveillance involves monitoring the ongoing safety of approved and marketed drugs under their usual conditions of use. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and by recommending ways of appropriately managing those risks. The FDA will often use this information to update drug labeling and to reevaluate the approval or marketing decision. The Weinberg Group offers the following services related to post-marketing surveillance:
- Design and analyze post-marketing surveillance studies, programs, and registries
- Detect and evaluate signals
- Provide risk management strategy and program support
- Perform routine surveillance and analysis of scientific and clinical literature
- Deliver technical and regulatory support for unexpected safety issues and products in crisis
- Design and implement risk minimization action plans
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