Regulator

FDA

Track U.S. Food and Drug Administration pharmacovigilance activity in one place: safety communications, medical device recalls, labeling change orders, and postmarketing ICSR standards. PV Bulletin surfaces FDA updates that affect adverse event reporting, the Adverse Event Monitoring System (AEMS), ICH E2B(R3) electronic submissions, and inspection-ready SOP impacts for drug safety teams.

2 updates · Sorted by impact priority

publicFDA · USA · Updated Jun 4, 2026

FDA Final Guidance on Postapproval Requirements and Resources for ANDAs

Urgency: Low

Review the guidance to ensure compliance with post-marketing safety reporting timelines and annual report submissions; update SOPs for ICSR processing and periodic report generation.

Country ComplianceICSRRegulatory Intelligence Lead

SOP Impact3 SOPs

ConfidenceHigh

Relevant for: Regulatory Intelligence Lead, Labeling Lead, QPPV

verifiedRegulatory action: Guideline

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publicFDA · USA · Updated Jun 5, 2026

FDA Intent to Exempt Certain Unclassified Medical Devices from 510(k) Requirements

Urgency: Low

Identify which unclassified medical devices are affected by the exemption; update regulatory submissions and post-market surveillance plans accordingly; ensure compliance with general controls and post-market surveillance obligations.

Country ComplianceRegulatory Intelligence Lead

SOP Impact1 SOPs

ConfidenceLow

Relevant for: Regulatory Intelligence Lead, QPPV

verifiedRegulatory action: Guideline

Read impact briefarrow_forward

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