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Sharan Murugan
- Feb 7
- 2 min
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...
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Sharan Murugan
- Sep 23, 2022
- 1 min
USFDA Guidance: Electronic Submission Template for Medical Device 510(k) Submissions
This document was issued on September 22, 2022. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be...
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Sharan Murugan
- May 2, 2022
- 1 min
USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide
This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...
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