The US Food and Drug Administration (FDA) has approved a cranial electrotherapy stimulator (Cervella, Innovative Neurological Devices) for treatment of anxiety, depression, and insomnia, the company has announced. Cervella, which requires a prescription, delivers micro pulses of electrical current acros...
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The FDA approved a controversial weight-loss device this month that allows obese patients to literally pump food from their stomach, through a tube, out their belly, and into the toilet. The AspireAssist consists of a surgically implanted tube that runs from the stomach to a small nozzle outs...
An applicant must notify FDA of a change to an approved application in accordance with all ...
Medical technology has been trending towards smaller, more discreet devices, but not every innovation that benefits patients makes it to the market. So it’s big news that the FDA just approved the Micra Transcatheter Pacing System (Micra TPS), theworld’s smallest pacemaker, at about one-tenth...
Dong-A ST said Accord Biopharma, a subsidiary of Intas Pharmaceutical, has received approval for the latter's biologics license application (BLA) for DMB-3115, a biosimilar referencing Stelara (ingredient: ustekinumab) to the FDA. The FDA approved the biologics license application for Dong-A ST'...
(CBER) Center for Devices and Radiological Health (CDRH) Office of Good Clinical Practice (OGCP) January 2009 Procedural Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Additional copies are available from: Office of ...
The institutional review board (IRB) at Stanford University approved the study protocol, which granted a waiver of parental consent for participants under 18 because the survey was anonymous, to maintain the privacy of participant use patterns, to prevent a breach of confidentiality regarding ...
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1、Guidance for Industry and FDA Staff:Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA)Waiver Applications for Manufacturers of In Vitro Diagnostic DevicesDocument issued on: January 30, 2008The draft of this guidance document was released on September 7, 2005.For questions...