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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
Jul 272 min read
USFDA Guidance: Providing Over-the-Counter Monograph Submissions in Electronic Format
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released a final guidance titled "Providing...
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