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USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
The United States Food and Drug Administration (USFDA) has released detailed guidance" Standardized Format for Electronic Submission of...

Sharan Murugan
Dec 9, 20242 min read
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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...

Sharan Murugan
Feb 7, 20242 min read
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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...

Sharan Murugan
Sep 23, 20221 min read
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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This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...

Sharan Murugan
May 2, 20221 min read
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