FDA’s new drug safety surveillance system is up and running, though the implications for safety oversight are only just beginning to be felt. But the conversation is already under way about what else Sentinel can do—and the answers may be very important to the future of drug regulation.
FDA’s Sentinel post-marketing surveillance system relies on what is known as "secondary use” of health records. That is, the system analyzes data created for one purpose (to process insurance claims) for a completely different reason (to answer research questions about outcomes of therapy, and especially adverse events).
The application of health claims data to regulatory purposes is, in fact, the key accomplishment of the Sentinel project to...
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.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
