by Admin | Mar 23, 2026 | Careers
This week’s major U.S. developments include FDA’s requirement for a vitamin B6 deficiency and seizure warning on carbidopa/levodopa products and the agency’s request to remove suicidal ideation and behavior language from certain GLP-1 RA labels after finding no...
by Admin | Mar 23, 2026 | Inspections & Compliance, Regulatory Updates
FDA says AEMS is its new Adverse Event Monitoring System, and the agency also maintains a dedicated page for new safety information or potential signals of serious risks identified through that system. Separately, FDA’s Drug Safety Communications page is updated with...
by Admin | Mar 23, 2026 | Careers, Regulatory Updates
FDA says its comprehensive review of available data did not identify an increased risk of suicidal ideation or behavior with GLP-1 RA medications and therefore requested removal of that warning language from affected labels. The agency also points to a large...
by Admin | Mar 23, 2026 | Careers
EMA published meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) for 10–12 March 2026. The agency says the meeting was followed by EMA Veterinary Medicines Info Day 2026 on 12–13 March, providing stakeholders with updates on regulatory...
by Admin | Mar 23, 2026 | Careers
EMA’s “What’s new” page lists a new event for European Shortages Monitoring Platform (ESMP) training on readable IDs and general updates for industry dated 20 March 2026. EMA also says ESMP is the platform through which marketing authorisation holders and national...
