Articles related to FDA

Mobile health apps are projected to continue rapid growth. Given the variety within the space, it will be increasing important for developers to understand and comply with applicable laws.

With 1 in 7 American adults being affected by chronic kidney disease, the American Society of Nephrology, in partnership with federal agencies, are laying the groundwork for treatment innovation.

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.

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.

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.

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).

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

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.