Business · 05/02/2004Updated: 10/17/2026 · 1 min read

FDA Publishes Guidance on Periodic Safety Update Reports for Marketed Drugs

The FDA has released a guidance document outlining the format and content of Periodic Safety Update Reports (PSURs) for marketed drugs, in line with the International Conference on Harmonisation's E2C guidance, aimed at harmonizing postmarketing clinical safety data collection and submission.