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FDA chief touts changes, modernization within agency

In an interview with Scripps News, Dr. Martin A. Makary touted the agency’s early rollout of an AI tool to assist reviewers in evaluating drug and device applications.
FDA chief touts changes, modernization within agency
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FDA Commissioner Dr. Martin A. Makary said the agency is taking aggressive steps to modernize outdated regulations, expand choice and improve efficiency.

Makary said infant formula standards haven’t changed in 26 years, aside from one addition of selenium. “There’s been no innovation in the space,” he said, noting growing demand for cleaner products without corn syrup, added sugars or heavy metals. The FDA is convening a panel to examine the regulatory barriers and update the formula recipes manufacturers are required to follow.

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On COVID-19 vaccines, Makary told Scripps News that the agency is now taking a more measured approach, adding the FDA will no longer issue blanket recommendations for healthy children.

"I think people need to remember the government is not your doctor," he said.

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Makary also touted the agency’s early rollout of an AI tool to assist reviewers in evaluating drug and device applications, calling it an "incredible success.” The software, named Elsa, has cut review time by days and is being expanded agencywide.

Despite recent staffing cuts, Makary said no scientific reviewers or food inspectors were let go. Instead, reductions targeted administrative and communications staff in an effort to redirect resources to the FDA’s core mission, he said.

"We created a culture of teamwork," he said. "We're going to continue to work to build that culture and create more of a friendly relationship with consolidated resources."

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