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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...

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...