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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.
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Pharma conference digs into Gilead case, executive orders, CMS audits
At the annual pharmaceutical compliance event, speakers discussed the Gilead False Claims Case and Trump administration initiatives.
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Pharma watch: Delayed vaccine decisions, insulin price lawsuit, drug cap win
Updates on US pharmaceutical policy, compliance, and regulation.
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Indian pharma faces challenge from Trump tariffs and US regulators
The US is the third largest importer of drugs made in India. But President Trump’s tariffs plan could derail bilateral trade ties.
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GRIP Extra: SEC Commissioner cautions against rapid deregulation, Greenpeace held liable for $650m
Other news includes the SEC ceasing its defenses of its climate disclosure rule, Fidelity launching its own stablecoin, and UBS limiting its size to skirt capital requirements.