FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time reducing paper consumption, increasing accessibility and providing rapid means for editing and updating content.
News & Trends
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Recentes
- EMA’s ePI Roadmap
- Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
- The new CTIS Sponsor Handbook (v6.2, March 2026)
- New revision of the Q&A document on art. 10(a) interruption of supply published
- IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
- New Harmonised Standards under MDR – April 2026
- EMA/CHMP: Updated Guideline on Active Substances published
- Data Quality Framework for EU medicines regulation: application to Real-World Data

