The U.S. Food and Drug Administration’s (FDA) approval of the first-ever disease-slowing therapy for Alzheimer’s has given hope to millions of Americans, their families, and caregivers who are all ...
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FDA set to pilot test real-time tracking of clinical trials
A new system will alert FDA officials of study results in real time.
The FDA is testing real-time clinical trial reporting in an effort to speed up the drug review and approval process.
FDA officials want more AI in the review process. The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in ...
On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...
And FDA explains that they don’t have any extra. Congress has been underfunding FDA for decades, and the agency only stays afloat now by virtue of user fees the industry pays to get submissions ...
President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.
The head of the Food and Drug Administration asked the agency’s watchdog on Friday to determine if any interactions between a biotechnology company and FDA officials were inappropriate in the review ...
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