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Sharan Murugan
Mar 302 min read
USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports
Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
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Sharan Murugan
Mar 17, 20231 min read
Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...
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Sharan Murugan
Jul 31, 20221 min read
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for...
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