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STAT+: FDA pushes drugmakers to report missing clinical trial results
In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.
In a bid toward greater transparency, the Food and Drug Administration sent reminder letters to more than 2,200 companies and researchers that they are required to report clinical trial results to a federal government database or they may face fines.
FDA officials disclosed that an internal analysis found results were not submitted for nearly 30% of studies that were “highly likely” to fall under mandatory reporting requirements. The agency also noted that the letters were sent to companies and researchers associated with more than 3,000 registered trials, some of which were publicly funded.
In explaining its move, the regulator acknowledged a long-standing complaint from researchers who have argued that without access to specific data, trial results cannot be easily duplicated, which inhibits greater understanding of how medicines might work. They also contend this can adversely affect treatment decisions and health care costs.
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Amgen shores up Tavneos’ FDA defense with Duke data analysis
Amgen shores up Tavneos’ FDA defense with Duke data analysis
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval. Read More
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Chile offers new data on food warning label efficacy
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So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
So much news today that I didn’t have space to write an item about hot tubs as a breeding ground for Legionnaires’ disease. Here’s the CDC report, if you’re curious.
The RNA-based medicine is one of a handful of antibody-oligonucleotide conjugates that Novartis acquired last October when it took over neuromuscular-focused Avidity Biosciences.
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