E6 Good Clinical Practice

The link provided contains the E6 Good Clinical Practice:Consolidated Guidance from ICH and FDA CDER and CBER. There are several sections addressing data and record handling including electronic records such as Section 5.5.3.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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