Search for: "WILLIAM MAISEL"
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11 Dec 2023, 8:33 pm
By Allyson B. [read post]
26 Jun 2023, 7:16 am
By Sophia Williams Launched in 2020, Warfare of Art & Law, a podcast hosted by attorney and artist Stephanie Drawdy, is a trove of conversations exploring how “justice does or doesn’t play out when art and law overlap. [read post]
8 Nov 2022, 8:56 pm
William Maisel, Chief Medical Officer and Director at CDRH’s Office of Product Evaluation and Quality, shared FDA’s experience with EUAs over the last two and a half years as well as more detail on transition planning for those devices marketed under an EUA or enforcement policy (EP). [read post]
8 Jun 2021, 2:39 pm
Maisel & Assocs. of Mich., 369 N.W.2d 492, 498 (Mich. 1985)). [read post]
8 Feb 2021, 8:57 am
JURIST EXCLUSIVE – A coalition of international legal advocates sent a joint letter Saturday to Professor Mary Lawlor, the UN Special Rapporteur on Human Rights Defenders, condemning the growing trend of government officials intimidating and endangering the legal representatives of politically controversial clients. [read post]
17 Jul 2020, 2:20 pm
William H. [read post]
17 Jul 2020, 2:20 pm
William H. [read post]
11 Apr 2020, 5:16 am
Fraud by the litigation industry takes many different forms. [read post]
10 Apr 2019, 6:05 am
” William Maisel, MD, MPH, chief medical officer of the agency’s Center for Devices and Radiological Health, said in a statement, “The agency’s analysis of adverse events associated with surgical staplers and implantable staples is ongoing, but we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk. [read post]
7 Apr 2016, 6:14 am
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientific in the FDA’s Center for Devices and Radiological Health. [read post]
9 Dec 2015, 4:02 pm
“When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. [read post]
19 Jan 2015, 7:14 am
” William Maisel, chief scientist at the FDA’s Center for Devices and Radiological Health, told reporters Monday “We believe the recommendations are appropriate and put appropriate restrictions on the use of laparoscopic power morcellation. [read post]
25 Nov 2014, 3:33 am
“We believe that in the vast majority of women, the procedure should not be performed,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.The move strengthens guidance the FDA issued in April and draws tight boundaries around use of a device that divided gynecologists and alarmed women. [read post]
3 Jun 2014, 8:18 am
HealthDay quoted William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, from a press release, “The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. [read post]
22 May 2014, 3:13 pm
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of patients,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. [read post]
29 Apr 2014, 8:58 pm
FDA takes a Stand According to William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, “the FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. [read post]
18 Mar 2014, 7:39 am
For its part, the FDA “says it is ‘well aware of under-reporting of adverse events’ and is working to improve the system, said William Maisel, chief scientist at the agency’s unit that oversees devices. [read post]
16 Dec 2013, 10:19 am
William Maisel, chief scientist at the FDA’s device unit, defended the BSD study ordered by the agency. [read post]
23 Apr 2013, 1:17 pm
William Maisel with the Center for Devices and Radiological Health (CDRH) announced plants could also be inspected, although historically the FDA has not had the personnel to inspect plants overseas. [read post]
14 Aug 2012, 11:23 pm
The FDA’s chief scientist for medical devices, William Maisel, has said, “The FDA has been aware of some of these problems for three years and has made recommendations in the past, but I think what you'll see coming out of these meetings are more specific recommendations for follow-up care. [read post]
