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Court Rules on FDA Ban of Electrical Stimulation Treatment


Health
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10 hours ago
The District of Columbia Circuit Court of Appeals issued a decision Tuesday regarding the Food and Drug Administration’s (FDA) controversial ban of the use of electrical stimulation devices as a treatment for self-harming individuals. The petitioner, the Judge Rotenberg Educational Center, Inc. (the Center), argued that the defendant lacked standing to make decisions regarding the implementation of medical devices in medical practices.
The Center is a facility that “treats patients with severe mental disabilities.” These disabilities can lead to the patients inflicting harm upon themselves, which the Center has sometimes treated using an electrical stimulation device. The device “briefly shocks patients causing them to reduce or cease their self-injurious behaviors.” Around 20% of patients are treated using this method, and the Center is the only facility in the country that uses this treatment on individuals who self-har ....

Phelps Mcnamara , Rotenberg Educational Center Inc , Drug Administration , District Of Columbia Circuit Court , Todd Weld , Columbia Circuit Court , Judge Rotenberg Educational Center , Eckert Seamans Cherin , ஃபெல்ப்ஸ் மக்நமர , ரோட்டன்பெர்க் கல்வி மையம் இன்க் , மாவட்டம் ஆஃப் கொலம்பியா சுற்று நீதிமன்றம் , டாட் பற்றவைப்பு , கொலம்பியா சுற்று நீதிமன்றம் , நீதிபதி ரோட்டன்பெர்க் கல்வி மையம் , எக்கேற்ட் கடற்படையினர் செரின் ,

BioSpace Movers & Shakers, May 21


Published: May 21, 2021
By Alex Keown
Biopharma and life sciences companies strengthen their leadership teams and board with these Movers & Shakers. 
AavantiBio – Jessie Hanrahan was named chief regulatory officer of AavantiBio. Hanrahan will oversee global regulatory affairs for AavantiBio’s diversified pipeline of gene therapy programs targeting rare diseases with significant unmet medical needs. Most recently, she was Vice President of Regulatory Science at bluebird bio, Inc. Prior to bluebird bio, Hanrahan held positions of increasing responsibility at Genzyme Corp. where she worked across the oncology, multiple sclerosis and rare disease therapeutic areas. Earlier in her career, Hanrahan worked at Boston Scientific Corporation. ....

United States , Stephen Basso , Inozyme Pharma , Phelps Mcnamara , R Michael Carruthers , Synageva Biopharma , Peter Pechan , Sierk Poetting , Jens Hosltein , Lucio Tozzi , Bradley Glover , Bristol Myers Squibb , Mark Pennesi , Guy Levy , Evelo Biosciences , Tyler Ralston , Johna Hohneker , Aeglea Biotherapeutics , Sigurdc Kirk , Irena Melnikova , Christian Weyer , Iveric Bio , Umoja Biopharma , Robert Doebele , Stephen Boyer , Timothy Noyes ,