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Sharan Murugan
Sep 152 min read
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
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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
Jun 26, 20221 min read
USFDA Guidance on Providing Regulatory Submissions in Alternate Electronic Format
This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...
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