Search results
Results from the WOW.Com Content Network
The results highlight the outstanding hemodynamic performance of the Trifecta valve (the ability to maximize blood flow through the valve), further confirm safety, and describe its ease of use.
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
A global safety monitoring board of WHO physicians examine interim results to assist decisions on safety and effectiveness of the trial drugs, and alter the trial design or recommend an effective therapy. [2] [5] A similar web-based study to Solidarity, called "Discovery", was initiated in March across seven countries by INSERM (Paris, France ...
In October, the FDA issued the clinical hold due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S. who ...
Before the Adding Ebola to the FDA Priority Review Voucher Program Act in 2014, this requirement was 365 days, which was a hindrance to the process of speedy review, as companies do not typically determine when drugs will be submitted until the results of safety studies are available. [2] Companies may also sell vouchers to other drug companies.
(Reuters) - The U.S. Food and Drug Administration said on Thursday cancer therapies that use CAR-T technology will require changes to the so-called "boxed warning" to highlight the serious risk of ...
Endobronchial valves are medical devices that allow air to exit these sections but not to re-enter. The valves, in effect, cause damaged lung tissue to deflate, thereby reducing the excessive lung volume (hyperinflation) caused by emphysema. Two endobronchial valves have been approved by the FDA for BLVR: Zephyr and Spiration. [citation needed]
By Sriparna Roy and Mariam Sunny (Reuters) -Advisers to the U.S. health regulator on Friday voted against the use of Novo Nordisk's weekly insulin in patients with type 1 diabetes due to risks of ...