A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information. Since 2010, Drug Safety Communications have replaced a variety of audience-focused tools laid out in a 2007 guidance, but FDA says public health alerts will be used to communicate about products that pose an immediate danger.
FDA’s Drug Safety Communications will not supplant other ways of conveying information about tainted or adulterated drug products that pose a public health threat, the agency said in a new draft guidance that explains the Center for Drug Evaluation and Research’s approach to communicating drug safety information.
Although DSCs communicate important safety information (see box), they are not crisis communication documents, the agency said in the new...
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.
The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.
An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.
