FDA
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FDA launches unified adverse event reporting dashboard
In addition to consolidating adverse events for all regulated products, the new centralized platform will manage consumer complaints, regulatory misconduct reports, and whistleblower submissions.
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FDA to streamline biosimilar development to lower drug prices
New federal guidance recommends using drugs approved outside of the US as comparators to cut down on pricey pharmacokinetic testing.
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FDA issues warnings to 30 telehealth companies over marketing violations
The letters warning of false or misleading marketing claims point to a transition from the agency’s traditional complaint-driven oversight to a more proactive monitoring system.
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Epic Systems, Oracle Health submit recommendations for HHS AI guidance
Both stakeholders say that AI should support clinical workflows and that clinicians should maintain decision-making authority.
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FDA announces new regulatory framework for ultra-rare disease therapies
The guidance will enable the agency to accelerate approval on new treatments for diseases affecting fewer than 1 in 50,000 people.
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FDA swiftly reverses RTF decision on Moderna flu shot candidate
The regulator is allowing the pharma giant’s revised biologics licensed application to proceed to review.
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RTF flu vaccine letter heard around the world
The FDA issued an extremely rare refuse-to-file letter related to Moderna’s new mRNA flu vaccine.
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Medicine show: White House launches TrumpRx
The drug platform is designed to reduce the cost of widely used medications, but critics say the prices are still higher than what insurance plans offer.