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
- Considerations for Complying With 21 CFR 211.110 Guidance for Industry
- Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
- New EU rules for health technology assessments become effective
- ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
- Inter-association joint position paper on Electronic Product Information
- MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
- Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
- Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway