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Public Citizen

Public Citizen demands FDA resignations after aducanumab approval 

June 16, 2021 By Brian Buntz

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” over FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm). Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider […]

Filed Under: Featured, Pharmaceutical Tagged With: Aducanumab, Aduhelm, Alzheimer’s disease, amyloid-beta plaque, Billy Dunn, Janet Woodcock, Patrizia Cavazzoni, Public Citizen, Xavier Becerra

Public Citizen pushes FDA to recall Sanofi’s Seprafilm

July 8, 2015 By Brad Perriello

(Reuters) — Consumer watchdog Public Citizen said it petitioned the FDA to withdraw approval of Sanofi‘s (NYSE:SNY) Seprafilm and order a recall, saying the surgical implant has been associated with side effects including death. Seprafilm, developed by Sanofi subsidiary Genzyme, is used to reduce abnormal internal scarring following surgery, by separating tissues and organs while they […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Surgical Tagged With: Genzyme Corp., Public Citizen, Sanofi-Aventis

FDA rejects ban on pelvic mesh, supports reclassification

July 16, 2014 By Arezu Sarvestani Leave a Comment

FDA rejects ban on pelvic mesh

FDA regulators refused this week to ban U.S. sales of pelvic mesh implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen, but offered some consolation in a potential reclassification of the devices to a higher-risk category.

Filed Under: Food & Drug Administration (FDA), Implants, News Well, Recalls, Women's Health Tagged With: Pelvic Mesh Lawsuits, Personal Injury, Public Citizen

FDA: Safety, efficacy, public health – and economy?

April 19, 2012 By MassDevice staff Leave a Comment

Capitol Hill

FDA officials and consumer advocates balked yesterday at legislative attempts to alter the federal watchdog agency’s mission statement to include promoting job growth, competition and economic growth.

A U.S. House version of a bill reauthorizing FDA user fees for medical devices and pharmaceuticals would include economic obligations FDA officials said would distract from the agency’s responsibility to patients.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Center for Devices and Radiological Health (CDRH), MDUFMA, Public Citizen, U.S. House of Representatives

Brain-stim studies tout safety amid battle over stricter FDA standards | MassDevice.com On Call

March 9, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

MASSDEVICE ON CALL — Brain stimulation using electrical currents is a safe and effective depression therapy and may even have other surprise perks for the body, according to research conducted at the University of New South Wales.

More than half of all patients in what researchers called the largest and most definitive study of transcranial direct current stimulation experienced "substantial improvements" after getting the therapy, according to a press release.

Filed Under: Legal News, Medicare, Neuromodulation/Neurostimulation, News Well Tagged With: Alpha-Stim, Education, On Call, Public Citizen, U.S. House of Representatives

Consumer group demands PMA for brain stimulation devices

March 7, 2012 By MassDevice staff Leave a Comment

neuron

Consumer advocacy group Public Citizen petitioned the FDA to require a more stringent standard for cranial electrotherapy stimulator devices, after a panel of agency experts recommended that the products not be downgraded to a lower-risk category.

The FDA’s Neurological Devices Panel met last month to discuss whether CES devices need more regulatory oversight, concluding that "since the benefits did not outweigh the risks, the device should be Class III."

Filed Under: Food & Drug Administration (FDA), Neuromodulation/Neurostimulation, News Well Tagged With: Alpha-Stim, Public Citizen

Stryker’s Wingspan brain stent gets a date with the FDA

February 13, 2012 By MassDevice staff Leave a Comment

brain vasculature

The FDA’s neurological devices panel will review clinical data from trials of Stryker’s (NYSE:SYK) Wingspan brain stent system next month, aiming to address harsh criticisms and public petitions urging the agency to recall the device.

The panel plans to consider pre-market and post-market data about the device, including the Gateway PTA balloon catheter and stent delivery system, to address concerns that Wingspan may lead to heightened risk of stroke or death.

Filed Under: News Well, Recalls, Stents Tagged With: Boston Scientific, Center for Devices and Radiological Health (CDRH), Neurovascular repair, Public Citizen, Stryker

MassDevice.com +3 | Public group vies for Stryker recall, Doc fix extended 2 months, Philips lands HeartNavigator clearance

December 23, 2011 By MassDevice staff Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you’re still in the know with MassDevice +3.

Filed Under: Healthcare Reform, Legal News, News Well, Recalls, Stents Tagged With: Centers for Disease Control & Prevention (CDC), Philips, Public Citizen, Stryker, U.S. House of Representatives, U.S. Senate

Former CDRH director joins Public Citizen in demanding recall of Stryker’s brain stent

December 22, 2011 By Arezu Sarvestani Leave a Comment

Updated Dec. 22, 2011, at 12:30 p.m. to include comments from Stryker.

Brain stenting

Consumer watchdog group Public Citizen asked the federal government to recall Stryker Corp.’s (NYSE:SYK) Wingspan brain stent over concerns that it may lead to heightened risk of stroke and death.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls, Stents Tagged With: Clinical Trials, Public Citizen, Stryker

Former CDRH director supports Public Citizen’s petition to recall Stryker’s Wingspan brain stenting system

December 22, 2011 By MassDevice Leave a Comment

December 20, 2011

Dear Dr. Wolfe

I write this note in support of your petition to the FDA to withdraw the HDE approval from the Wingspan  stent and to request a recall of this device.

Filed Under: Recalls, Stents Tagged With: Public Citizen

Hacker outs Medtronic, five devices to save Steve Jobs, public watchdog demands mesh recall | MassDevice.com +3

August 25, 2011 By MassDevice staff Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you’re still in the know with Massdevice +3.

Filed Under: Food & Drug Administration (FDA), Health Information Technology, News Well, Women's Health Tagged With: Apple, Insulin Management, Public Citizen

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