Fewer PMA Approvals In FY 1998 Anticipated By Device Center's Alpert
This article was originally published in The Gray Sheet
Executive SummaryFDA expects to approve fewer than 40 original premarket approval applications in fiscal year 1998 (ending Sept. 30), down from the prior "banner year" in which the agency okayed 48, Office of Device Evaluation Director Susan Alpert forecast at a recent Food and Drug Law Institute meeting in Washington, D.C.
You may also be interested in...
New medicines under evaluation at the European Medicines Agency.
Discussions on the shape of health care have moved from “reimagining” to the next stage: building and executing on the vision. That is the thrust of EY’s NextWave Report: New Horizons 2019. Additionally, for medtechs seeking business continuum, “duality” is now a preoccupying thought.
The idea that public corporations have obligations that extend beyond the fiduciary responsibility to shareholders will be the dominant measure of responsible business behavior in the coming decade. Uncertainty about the extent of these commitments – commonly referenced as the environmental, social and governance (ESG) agenda – has produced equally variable responses from companies in the health care business.