Efforts to foster innovation may have been the major theme for FDA in 2013, with new and expanded programs to expedite review of drugs for unmet medical needs dominating headlines, but senior agency officials also describe continued advances on the safety side of the regulatory equation.
Improvements in safety assessment and greater mechanistic understanding of common adverse events could produce fewer safety-related market withdrawals in the future, recent comments by two leading FDA authorities suggest.
“Some of the major causes of drugs going off the market, I think, are largely gone” because of systematic, prospective...
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 UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.
