Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.

Update product labeling to include Lisraya as the first oral treatment for dermatomyositis, ensuring that all marketing and educational materials reflect its approval and associated safety information.

Review and update internal compliance and reporting workflows to align with the FDA's reporting requirements for the latest oncology product approvals.

Cattle producers must administer Bimectin injection within specified timelines (24 hours post-birth, at castration, or on wound appearance) and observe a 35-day withdrawal period before slaughter to prevent drug residues in food.

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

Customers must immediately identify and quarantine all unused affected devices (Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636) and return them to Medtronic for replacement.

Veterinary practitioners must now adjust their prescribing practices in accordance with the AMEG guidelines and monitor compliance with the new restrictions as outlined in the EMA's directive.

Comments on the draft guidance must be submitted by November 27, 2026. Facilities must comply with CGMP in accordance with specified enforcement policies to avoid potential enforcement actions.