Although major pharmaceutical companies do not appear to be rejecting the proposal in FDA's draft guidance on drug-induced liver injury that trials enroll patients with preexisting liver disease, according to comments submitted on the draft, the companies would like to see more clarification on how such patients should be included
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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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.
