PV Bulletin

Tag archive

Fda.gov

publicFDA · USA · Updated Aug 25, 2026

Pain and Arthritis Products Containing Hidden Ingredients

Urgency: High

Monitor and reassess affected pain and arthritis products, ensuring compliance with safety reporting protocols for products listed with known hidden ingredients.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Signal Management Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Qu Feng Huo Lou Dan May Be Harmful Due to Hidden Ingredient

Urgency: High

Consumers should consult healthcare professionals if using this product and report any adverse effects to FDA’s MedWatch Safety Information.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Signal Management Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

Urgency: High

Healthcare providers and manufacturers must now comply with new reporting obligations for adverse reactions associated with the use of Imaavy and ensure adherence to increased compliance requirements for its administration.

LabelingSignal ManagementRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Ongoing Accelerated Approvals for Infectious Disease Products

Urgency: High

Regulatory intelligence teams should review ongoing studies and compliance with postmarketing requirements for the drugs listed, specifically focusing on their deadlines for completion and the nature of the studies required.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

Urgency: High

Stakeholders should incorporate the device authorization into labeling and signal management protocols to ensure compliance and effective communication regarding its capabilities.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Labeling Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicFDA · USA · Updated Aug 25, 2026

Guidance on Use of Clove Oil as Anesthetic for Fish

Urgency: High

Regulatory intelligence teams must update workflows to exclude clove oil as an anesthetic for fish and ensure compliance with the guidance, including awareness of approved alternatives.

Signal ManagementRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward

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