Pharma & Drug Safety

Health Commissioner Statement on Court Ruling and Vaccine Science

New York State Health Commissioner Dr. James McDonald issued a statement on a federal judge's ruling concerning the Advisory Committee on Immunization Practices (ACIP). The statement reaffirms the department's commitment to vaccine science and protection against preventable diseases.

Integra LifeSciences Convenience Kit Needle Recall

The FDA is alerting the public about a recall initiated by Integra LifeSciences for certain Convenience Kit Needles, specifically the Codman Microsensor Basic Kits and Cerelink ICP Sensor Basic Kits. Affected customers and distributors are instructed to immediately remove these devices from service or distribution.

FDA: Dialysis Tubing Sets Recalled Due to Dislodging, Updated Instructions

The FDA is alerting healthcare providers about a recall of Vantive dialysis tubing sets due to potential dislodging of the deaeration chamber. Updated instructions for use have been issued to mitigate risks, emphasizing monitoring the chamber during therapy. This is a correction and does not involve removing the devices from use or sale.

DEA Seattle Fentanyl Enforcement and Awareness Initiative

The DEA's Seattle Division is launching a "Fentanyl-Free America" initiative in the Pacific Northwest, focusing on increased enforcement, education, and awareness. This initiative aims to combat the fentanyl crisis through collaborative efforts.

DEA Seizes Over Half a Million Vape Cartridges and Drugs in San Diego

The DEA announced a massive seizure in San Diego, confiscating over half a million vape cartridges and other illicit drugs. This action highlights the ongoing threat posed by illegal substances to public health and safety, with multiple law enforcement agencies collaborating in the operation.

MHRA Field Safety Notices for Medical Devices

The MHRA has published a list of Field Safety Notices (FSNs) for medical devices issued between March 9-13, 2026. These notices are for informational purposes, and recipients are advised to act on any FSN received from a manufacturer.

MHRA NICE Integrated Scientific Advice Service Guidance

The MHRA and NICE have updated guidance on their Integrated Scientific Advice (ISA) service for medicine developers. The updates provide additional information on preparing for ISA meetings, including specific guidance on writing questions, creating briefing books, and understanding ISA reports and fees.

VA Health Districts Partner with Jail to Improve Inmate Health Literacy

The Virginia Department of Health's Hampton & Peninsula Health Districts have partnered with the Virginia Peninsula Regional Jail to offer an eight-week health literacy program to incarcerated individuals. This initiative aims to reduce health disparities and improve health outcomes for those re-entering the community.

Virginia Health Department Closures and Early Closures

The Virginia Department of Health announced closures and early closures for various health departments and clinics on Monday, March 16, 2026. This notice details specific facilities and their operational status for the day.

EMA CHMP Agenda: Hetlioz for Smith-Magenis Syndrome

The European Medicines Agency (EMA) has published the agenda for an extraordinary CHMP meeting on March 16, 2026. The agenda includes discussions on the re-examination procedure for Hetlioz (Tasimelteon) for Smith-Magenis Syndrome, involving oral explanations and variations to marketing authorisations.