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<safetyreport>
<serious>1</serious>
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New
⚠ FDA Deadline: Apr 1, 2026
ICSR Compliance
The ICH E2B(R3) Deadline Is Here: What Small Biotechs Need to Know About ICSR Intake
The mandatory FDA deadline for electronic ICSR submissions is no longer on the horizon. Here is what IND sponsors need to do right now, starting with adverse event intake.
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New
ICSR Compliance
Adverse Event Intake vs. Full Pharmacovigilance: What Is the Difference?
Understanding where AE intake ends and full pharmacovigilance begins, and why the distinction matters for small biotech program design.
New
Pharmacovigilance
Why Veeva Vault Safety and Oracle Argus Are Overkill for Early-Phase Biotech Programs
A practical look at why enterprise PV databases are designed for large MAHs, and what small IND sponsors actually need instead.
GxP Compliance
21 CFR Part 11 and GAMP 5 for Adverse Event Systems: A Practical Primer
What validated systems actually require for electronic records in a pharmacovigilance context, written for teams without a dedicated IT compliance function.
Pharmacovigilance
Building a Pharmacovigilance Plan for Your First IND: What Small Biotechs Get Wrong
Common PV plan gaps at early-phase biotech programs and the minimum viable structure that satisfies FDA expectations without overspending.