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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 CDRH plans to publish 11 final guidance documents and three draft guidance documents this fiscal year.

The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program. The program aims to transform how clinical trials are designed and conducted to streamline them and ultimately bring products to market sooner.

The International Coalition of Medicines Regulatory Authorities (ICMRA) issued a joint statement encouraging manufacturers and national control laboratories to reduce animal testing throughout the lifecycle of medicines. ICMRA also encouraged regulators to challenge any proposals that suggest using animals for batch release testing.

The Council of the European Union has adopted new rules for the pharmaceutical sector, advancing efforts to reform legislation governing the industry.

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