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The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and its priorities for FY 2027. Two key priorities for the future include a proposal to require public disclosure of new drug applications (NDAs) and biologics license applications (BLAs) upon filing, as well as proactively publishing all inspection reports.

The European Commission has set out the need for the European Medicines Agency (EMA) to urgently advance preparations for the Biotech Act.

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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).

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

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.