FDA Reviews Drug Label Info Collection for Patient Safety
Published Date: 2/3/2025
Notice
Summary
The FDA is asking for approval to collect info about how prescription drug labels are made and used. This affects drug makers who must follow clear rules to keep labels easy to understand and safe. The goal? Make sure labels help people use medicines right without extra costs or delays.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Drug makers must provide labeling information
The FDA has submitted a proposed information collection to the Office of Management and Budget under the Paperwork Reduction Act of 1995. Drug makers would need to provide information about how prescription drug labels are made and used and follow clear rules intended to keep labels easy to understand and safe.
Labels aimed to be clearer and safer
The FDA says it will study how prescription drug labels are made and used so labels are easier to understand and safer. The stated goal is to help people use medicines correctly without creating extra costs or delays.
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Key Dates
Department and Agencies
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