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Sharan Murugan
- Mar 31
- 2 min
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, 2022
- 1 min
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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