Gerald Dal Pan indicated in an interview that the agency's safety systems as now constituted are generating the data needed and that so-called real-time surveillance, which is in place for COVID-19 vaccines and therapeutics, is not practical for all approved products.
Real-time surveillance for all approved drugs likely is not realistic or advisable for the US Food and Drug Administration, but can be switched on when necessary, Gerald Dal Pan, the director of the agency’s Office of Surveillance and Epidemiology, told the Pink Sheet in a recent interview.
The FDA has been conducting near real-time surveillance in specific situations for some time and Dal Pan indicated a selective approach would continue. Last year the agency continued its collaboration...
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 European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
