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Revised Draft Guidance

publicFDA · United States · Updated Aug 3, 2026

Revised Guidance on Irritation and Sensitization Testing for ANDAs

Urgency: High

Clinical safety and pharmacovigilance teams must update their study protocols and adverse event reporting procedures to align with the revised guidance by October 2, 2026.

ICSRCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, QPPV
verifiedRegulatory action: Revised Draft Guidance
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