U.S. Food and Drug Administration (FDA) news and information

The government shutdown isn't stopping Food and Drug Administration advisory committee meetings scheduled this month, according to drug and device manufacturers.
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A scientific panel that shaped the government's policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical firms seeking to affect the thinking of the FDA.
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The market for drug therapies for rare diseases is becoming increasingly crowded with expensive new products, a Modern Healthcare review of FDA approval and company pricing data shows.
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A scheduled House committee hearing on the Food and Drug Administration's progress toward implementing a federal law requiring it to develop a regulatory strategy for health information technology was postponed Thursday, as the government shutdown continued into its third day.
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The government shutdown has led to furloughs of about half of the staff at the Food and Drug Administration and the Health Resources and Services Administration and may lead to delays in the agencies' operations.
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A biotech drug from Roche has become the first medicine approved to treat breast cancer before surgery, offering an earlier approach against one of the deadliest forms of the disease.
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The House easily approved bipartisan legislation Saturday aimed at improving the safety of drugs produced by compounding pharmacies that mix customized pharmaceuticals.
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A bill in Congress aimed at strengthening oversight of compounding pharmacies would make drug compounders' participation in a new regulatory category voluntary rather than mandatory.
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The FDA would have greater oversight over large-volume compounding pharmacies like the company that triggered a deadly meningitis outbreak, under federal legislation winning bipartisan support.
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As the number and array of health apps for mobile devices continue to explode, the federal government will keep its regulatory focus on a narrow band of products that pose the most potential risk.
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