In Brief: Neopath AutoPap
This article was originally published in The Gray Sheet
Executive Summary
Neopath AutoPap: Firm submits prospective clinical data requested by FDA in support of its pending premarket approval application supplement for use of the AutoPap as a primary Pap smear screener. At a September 1996 meeting, FDA's Hematology and Pathology Devices Panel recommended against approval of the PMA supplement and called for additional prospective studies comparing conventional cytologist slide review to AutoPap review ("The Gray Sheet" Oct. 7, 1996, p. 8). The automated Pap smear analysis system was approved in September 1995 for quality control rescreening of previously screened Pap smear slides...
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.