FDA OUTSIDE CONTRACT FOR DEVICE EVALUATION/COMPLIANCE DOCUMENT CONTROL
This article was originally published in The Gray Sheet
Executive Summary
FDA OUTSIDE CONTRACT FOR DEVICE EVALUATION/COMPLIANCE DOCUMENT CONTROL should be finalized by late summer or early fall, according to FDA staff. The Center for Devices and Radiological Health, which decided in 1993 to contract out the services, has already selected the contractor and expects to begin negotiations on the price and specific duties covered by the deal within 30 days.
You may also be interested in...
Prestige Expands UK Eye Care Range In Response To Consumer Demand
A “great consumer response” to TheraTears in the UK leads Prestige Consumer Healthcare to add TheraTears 5-in-1 Irritation and Redness eye drops to the range.
Who’s Hired? Hikma Recruits New US Generics President
A flurry of top level recruitments made headlines in the past weeks, with the likes of Hikma, Lupin, and Viatris announcing new hires while focusing on their targets for the year.
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.