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Briefing No. 43 · October 26, 2026 · sent to subscribers

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Each issue is reproduced as it was sent. It reflects what was known at the time of sending and is not updated afterwards — follow the regulator links inside it for the current position.

SPEQ
Weekly GxP Briefing
Briefing No. 43 · Oct 26, 2026 · FDA · EMA · MHRA · Health Canada
 
This week: 1 MHRA alert · 5 Health Canada recalls · 3 new final FDA guidances.
The signal
 
FDA FINAL GUIDANCE
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Guidance for Industry
Oct 22, 2026
Read the record on SPEQ
Closing windows
 
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FDA COMMENT WINDOW
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
Comments close Oct 26, 2026
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FDA COMMENT WINDOW
Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Mis…
Comments close Oct 26, 2026
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FDA COMMENT WINDOW
Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments
Comments close Oct 26, 2026
EU EMA CONSULTATION
Reflection paper on methodological aspects in confirmatory platform trials
Opened Oct 19, 2026 · EMA publishes no closing date
The enforcement desk · FDA · EU · UK · Canada
 
UK DRUG SAFETY UPDATE
IXCHIQ Chikungunya vaccine: UK marketing authorisation withdrawn following safety review
Oct 20, 2026
CA HEALTH PRODUCTS
Azurion 7 Systems
Oct 21, 2026
FDA WARNING LETTER
CGMP/Finished Pharmaceuticals/Adulterated
Baxter International Inc. · Oct 20, 2026
CA HEALTH PRODUCTS
Femyso: Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons ins…
Oct 21, 2026
FDA WARNING LETTER
CGMP/QSR/Medical Devices/Adulterated
Olympus Medical Systems Corporation · Oct 20, 2026
Decoded
 
21 CFR 1.505 (FSVP)
The FSVP importer did not adequately evaluate the risk posed by a food and the foreign supplier’s performance — the analysis that sets how the supplier is approved and how intensively it must be verified.
The recurring root cause: Approving a supplier without a documented evaluation of the food’s risk and the supplier’s performance.
Read the full interpretation
 
Regulator facts above are reproduced from the issuing authority and link to the record on SPEQ. Blocks marked SPEQ READ are SPEQ's interpretation, not a regulator's instruction, and are not legal or regulatory advice.