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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.
Replimune’s second complete response letter for its cancer therapy last week is already leading to multiple rounds of layoffs and existential questions about the company’s future unless it can figure out a path forward with …
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STAT+: Congress returns to a packed health care agenda
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.
Trump deleted an AI image of himself on Truth Social looking a whole lot like Jesus after conservative Christians cried blasphemy. “It’s supposed to be me as a doctor,” Trump told reporters while stepping out of the Oval Office to get a McDonald’s delivery. Send news tips and surprising health care angles to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Recess is over
Congress returns to a packed health care agenda after two weeks off. Here’s what to follow.
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.
Trump deleted an AI image of himself on Truth Social looking a whole lot like Jesus after conservative Christians cried blasphemy. “It’s supposed to be me as a doctor,” Trump told reporters while stepping out of the Oval Office to get a McDonald’s delivery. Send news tips and surprising health care angles to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Recess is over
Congress returns to a packed health care agenda after two weeks off. Here’s what to follow.
Uncategorized
Travere wins long-awaited approval for kidney disease drug
The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually.
The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1 billion annually.
Illinois’ financial crisis could bring the state to a halt
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Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
Replimune looks ahead as repeat CRL speeds the company’s decline
STAT+: Congress returns to a packed health care agenda
Travere wins long-awaited approval for kidney disease drug
50 employees impacted as Astellas closes Universal Cells’ Seattle office
Revolution Medicines leads latest wave of stock offerings, totaling $1.5B
AWS Launches Amazon Bio Discovery Agentic AI to Accelerate Drug Development
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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