FDA

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FDA Approves Controversial Alzheimer's Drug

Jul 12, 2021 at 03:30 pm by Staff

On June 7, the Food & Drug Administration approved Aduhelm (aducanumab) to treat Alzheimer's patients, making it the first new drug approval for a disease impacting more t.... Read More

COVID-19, Mobile Health & the Importance of Maintaining Legal Compliance in an Era of Explosive Growth

Nov 18, 2020 at 02:02 pm by Staff

Renee Rayne Mobile health apps have become quite commonplace and are projected to continue rapid growth to become a $57.57 billion market by 2026. Although COVID-19 has create.... Read More

Taking the Initiative on Kidney Care

Mar 09, 2020 at 11:41 am by Staff

KHI, KidneyX, New Executive Order Create Collaborative Focus Recent data from the Centers for Disease Control and Prevention shows more than 35 million Americans are affected.... Read More

President Signs FDA User Fee Legislation

Aug 25, 2017 at 12:02 am by Staff

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.... Read More

Alexander Leads Bipartisan Support for Accelerated FDA Reviews

Aug 18, 2017 at 12:02 am by Staff

On Aug. 2, the U.S. Senate passed bipartisan legislation led by health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) intended to speed.... Read More

FDA Asks Endo Pharma to Pull Opana ER

Jun 09, 2017 at 11:42 am by Staff

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 hydroc.... Read More

FDA Approves Drug to Treat Duchenne Muscular Dystrophy

Feb 10, 2017 at 08:10 am by Staff

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 dyst.... Read More

21st Century Cures

Jan 10, 2017 at 02:28 pm by Staff

Bipartisan Law Has Broad Healthcare Implications Editor's Note: U.S. Senator Lamar Alexander (R-Tenn.), who chairs the Senate Committee on Health, Education, Labor & Pen.... Read More

FDA Approves Device for Prevention of Recurrent Stroke in PFO Patients

Oct 31, 2016 at 09:00 am by Staff

On Oct. 28, the U.S. Food and Drug Administration approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a st.... Read More