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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...
Sharan Murugan
Sep 15, 20242 min read
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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...
Sharan Murugan
Jul 27, 20242 min read
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