2025-07593Notice

FDA Updates Export Notification and Recordkeeping Feedback Request

Published Date: 5/1/2025

Notice

Summary

The FDA wants your thoughts on updating how companies report and keep records when exporting drugs, devices, food, cosmetics, and tobacco products. This affects businesses that send these products overseas and could change what info they need to share or save. You’ve got 60 days to speak up before any changes happen—so don’t miss your chance to weigh in!

Analyzed Economic Effects

1 provisions identified: 0 benefits, 0 costs, 1 mixed.

Exporters May Face Recordkeeping Changes

The FDA is asking for comments on proposed information collections for export notifications and recordkeeping for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco product exports. Businesses that send these products overseas could see changes to what information they must share or keep. You have 60 days to submit comments under this notice.

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Key Dates

Published Date
5/1/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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