PV Bulletin

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.

4 updates · Sorted by impact priority

publicMedicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) · United Kingdom · Updated Jun 15, 2026

Unique Liaison Programme between MHRA and FDA

Monitoring

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Signal ManagementCountry ComplianceRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead, QPPV
verifiedRegulatory action: Notice
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publicFDA · USA · Updated Aug 31, 2026

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

Monitoring

Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.

LabelingSignal ManagementRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
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publicFDA · USA · Updated Aug 26, 2026

Exemptions Granted to Small Business Dispensers Under the Drug Supply Chain Security Act

Monitoring

Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicFDA · USA · Updated Aug 25, 2026

Potency Assessment Guidance for Active Immunotherapy Products

Monitoring

Stakeholders are advised to submit comments on the draft guidance by 11/18/2026, using docket number FDA-2026-D-8561 to ensure FDA considers their feedback before finalizing the document.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward

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