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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than a decade old, the pace of change in pharmacogenomics has prompted regulators to revisit their recommendations.

The Medicines and Healthcare products Regulatory Agency (MHRA) says the UK government has adopted a list of recommendations on the use of artificial intelligence (AI) in medical devices developed by an independent group of doctors in the National Health Service (NHS). The agency also said it is initiating the third phase of its AI Airlock, a regulatory sandbox for evaluating new AI products.

The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their inspections. The guidance incorporates concepts from the International Council for Harmonization’s (ICH) Q9 (R1) guideline on quality risk management (QRM).

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The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Evolus for exaggerating efficacy claims for its drug Jeuveau (prabotulinumtoxinA-xvfs) and for “blurring the lines” between prescription products and consumer cosmetics on Instagram.

The US Food and Drug Administration (FDA) is seeking public input on how to design early-phase clinical trials to evaluate therapeutic uses of the plant-derived psychoactive drug ibogaine.

Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, we learned that the White House’s nominee to lead FDA won’t get a confirmation vote until after the US November mid-term elections, that FDA seems to be restrengthening its advisory committee system, and more.

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug Administration (FDA) Center for Devices and Radiological Health for fiscal year (FY) 2027, the center announced on 1 October. CDRH plans to publish 11 final guidance documents and three draft guidance documents this fiscal year.