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FDA PreCheck launches to strengthen domestic drug manufacturing
The FDA has unveiled FDA PreCheck, a two-phase program designed to speed approvals and boost regulatory certainty for US drug manufacturing projects.
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FDA sends Whoop warning over Blood Pressure Insights wearable
The FDA claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.
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Healthcare at a crossroads as America re-evaluates its approach
Significant developments in the healthcare sector are pulling at the integrity of the entire system.
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GRIP Extra: CFTC nominee Quintenz quizzed by senators, FDA to use AI for drug approvals
Our in-brief roundup of notable stories from last week.
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FDA launches AI tool for its medical researchers and investigators
The FDA has released Elsa, an AI tool designed to optimize the performance of FDA employees such as researchers and investigators.
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Drug prices in executive and legislative cross-hairs
The rising cost of prescription drugs is a concern for patients, healthcare providers and policymakers, but crafting a solution without undermining industry confidence is tricky.
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FDA announces AI rollout timeline and scientific review pilot completion
The FDA said its timing to scale use of AI inside its FDA centers follows the completion of a GenAI pilot for scientific review.
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FDA signals unannounced inspections at foreign manufacturing facilities
The FDA noted how foreign companies have been given advanced notice before facility inspections, while American manufacturers have not.