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President Signs FDA User Fee Legislation
President Signs FDA User Fee Legislation

On Aug. 18, President Donald Trump signed bipartisan legislation authored by Senate health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) intended to speed safe drugs and medical devices into patients' medicine cabinets and doctors' offices, while maintaining safety and effectiveness standards.

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Alexander Leads Bipartisan Support for Accelerated FDA Reviews
Alexander Leads Bipartisan Support for Accelerated FDA Reviews

By a vote of 94-1, the U.S. Senate has sent President Trump a bill addressing FDA user fee agreements meant to speed up the Food & Drug Administration's review of new drugs and devices.

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FDA Asks Endo Pharma to Pull Opana ER

In a highly unusual move, the U.S. Food and Drug Administration has requested Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. In a release on June 8, the agency said it is seeking removal based on concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

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FDA Approves Drug to Treat Duchenne Muscular Dystrophy
FDA Approves Drug to Treat Duchenne Muscular Dystrophy

On Feb. 9, the U.S. Food and Drug Administration approved Emflaza (deflazacort) tablets and oral suspension to treat patients age 5 years and older with Duchenne muscular dystrophy (DMD).

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21st Century Cures
21st Century Cures

Calling it a 'Christmas miracle,' U.S. Sen. Lamar Alexander discusses the importance of the 21st Century Cures Act.

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FDA Approves Device for Prevention of Recurrent Stroke in PFO Patients

On Friday, the U.S. Food and Drug Administration announced approval of the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a patent foramen ovale (PFO), and then traveled to the brain.

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