In Brief: Saline breast implant studies
This article was originally published in The Gray Sheet
Saline breast implant studies: As of Sept. 30, manufacturers Mentor and McGhan have enrolled 608 and 1329 patients, respectively, in a one-year prospective clinical trial on saline breast implants, according to figures presented by FDA device center Deputy Director for Regulations and Policy Joseph Levitt at the American Society of Plastic and Reconstructive Surgeons' annual meeting Oct. 7 in Montreal. The trials, scheduled to be completed in 1997, are expected to enroll approximately 3,000 patients by December. Mentor also has enrolled a total of 1599 patients (1268 augmentation/331 reconstruction) for a three-year prospective trial on the implants designed to address overall safety and quality of life issues. McGhan has enrolled 925 patients (820 augmentation/105 reconstruction) in the three-year trial...
You may also be interested in...
The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.
Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.
US FDA will simultaneously review the vaccines, with Moderna’s advisory committee set a week after Pfizer’s. ACIP emergency meeting scheduled for 1 December with vote likely on distribution priority for health care personnel.