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Feb 72 min read

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...

Sep 23, 20221 min read

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...

May 2, 20221 min read

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This Document supplements the Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND...