Gish Anticipates 510(k) Submission For EZ Flow 480 By 1999
This article was originally published in The Gray Sheet
Executive Summary
Gish Biomedical hopes to file a 510(k) submission with FDA by January 1999 to cover modifications to its previously marketed EZ Flow 480 Ambulatory/Pole mounted infusion pump following the receipt of a March 3 warning letter from the agency.
You may also be interested in...
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.