Rep. Cooper's 510(k)s
This article was originally published in The Gray Sheet
Executive Summary
Rep. Jim Cooper (D-Tenn.) is listed as the contact person for two 510(k) submissions for powder-free latex exam gloves cleared by FDA on June 6 and contained in FDA's list of June 510(k) clearances. Hartalega SDN BHD sponsored the 510(k)s. Cooper staffers say the Congressman has no financial interest in the firm and that his name appears on the list because his office probably sent FDA a cover letter on behalf of a constituent asking the agency to review the products
You may also be interested in...
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.
Taro Agrees $36m Securities Settlement Over US Price-Fixing Claims
Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a firefighters’ pension fund accused the firm of misleading investors via its involvement in generic price fixing, leading to a fall in the price of its securities.