This article was originally published in The Gray Sheet
Device center's office of compliance and surveillance will reorganize on a trial basis in late March or April following Commissioner-level clearance. OCS managers floated a proposal to reorganize the office according to product areas in December 1992 ("The Gray Sheet" Dec. 14, p. 2). The plan will be implemented for a three- to six-month period, after which its effectiveness will be evaluated. FDA has not yet decided whether postmarket surveillance activities will remain within OCS or be moved to the office of training and assistance. If shifted to OTA, that office also likely would reorganize by device areas, FDAers say.
You may also be interested in...
Pain relief product sales grew 27% and upper respiratory sales 35% for the week ended 7 March as consumers respond to COVID-19, according to Nielsen data noted in a Jefferies report on consumer health purchasing trends. Private label market share is up slightly, while OTC purchases continue primarily in conventional stores.
Managing partner Corey Goodman said venBio didn’t have trouble closing its fund, because the venture capital firm prepared its investors for an economic downturn months ago.
The US FDA has proposed moving two categories of hepatitis C diagnostics to class II from class III because they pose relatively low risk.