by Admin | Mar 22, 2026 | Regulatory Updates
FDA announced action to restrict unlawful imports of xylazine active pharmaceutical ingredients and finished dosage-form drug products into the United States. The agency said xylazine has increasingly been found in illicit drugs, including illicitly manufactured...
by Admin | Mar 22, 2026 | Regulatory Updates
MHRA updated its National assessment procedure for medicines guidance on 24 February 2026, setting out the agency’s UK national route for marketing authorisation applications. While not a pharmacovigilance page, this kind of pathway guidance matters because...
by Admin | Mar 22, 2026 | Regulatory Updates
MHRA’s Safety Roundup: February 2026 pulls together recent medicines and device safety information, including semaglutide-associated NAION and falsified Mounjaro pens, into a single regulator-issued summary. That makes it more than a newsletter-style update. It is...
by Admin | Mar 18, 2026 | Regulatory Updates
MHRA’s National assessment procedure for medicines guidance was updated on 24 February 2026. The page explains the agency’s national assessment procedure for marketing authorisation applications in the UK. Even though this is not a pharmacovigilance-specific page, it...
by Admin | Mar 18, 2026 | Regulatory Updates
MHRA’s Safety Roundup: February 2026 describes itself as a summary of the latest safety advice for medicines and medical device users. The roundup highlights recent issues including semaglutide-associated NAION and falsified Mounjaro pens, giving readers a concise...
by Admin | Mar 18, 2026 | Regulatory Updates
FDA has required an additional MRI between the 2nd and 3rd Leqembi infusions to help detect amyloid-related imaging abnormalities with edema, or ARIA-E, earlier in treatment. The agency said ARIA-E is often asymptomatic but can also involve serious and...
