One of the committee’s key recommendations is that FDA should create a benefit and risk assessment and management plan for each drug. This would be a single, comprehensive, publicly available document that serves as a central source of information for each product from its approval throughout its entire time on the market. The document should include:
• A description of any safety questions that exist when a drug is approved or that emerge over the course of the product’s use
• Benefit and risk assessments specific to these questions
• Details on regulatory actions taken on the medication
The FDA already gathers much of this information, but it is currently scattered across multiple records. Other proposals include postmarket research to ensure continued safety of approved drugs.
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