Showing posts with label approval. Show all posts
Showing posts with label approval. Show all posts

Friday, May 13, 2016

Experts Decry Tying Medical Research Funds to FDA Standards Changes

Experts Decry Tying Medical Research Funds to FDA Standards Changes-wallstreetjournal: Moves in Congress to link billions of dollars in new medical research funding to revised standards for drug and medical-device approvals are troubling some public-health experts, who say the combination makes it too easy for lawmakers to support lower patient-safety standards.

Thursday, June 18, 2015

FDA Approves Edwards' Sapien 3 TAVR System

FDA Approves Edwards' Sapien 3 TAVR System-graysheet: The third-generation transcatheter aortic valve has been available in Europe for over a year, will have a long head-start on rival Medtronic's next generation TAVR, Evolut R, in the U.S. market.