The U.S. Army needed 10 months to award a contract following a July 2022 request for proposals for flow cytometry and other clinical lab equipment, but Beckman Coulter Inc., filed an appeal that protested the award to Sysmex America Inc., of Lincolnshire, Ill. Beckman Coulter argued that Sysmex should have been disqualified from the bidding for failing to provide a technically acceptable proposal, but the Government Accountability Office decreed that the company’s protest failed because it was not filed within the required 10 days post-award.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: COVID-19 inventions included in USPTO awards program; First thrombosis incident reported in Australia; FDA revises Moderna EUA; GAO refuses to reconsider VA challenge.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA cites pivotal study failure for Lutonix 014; HHS adds to PREP Act immunity; Dermal fillers on tap at FDA advisory; GAO urges a pause in VA EHR deployment.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MITA unveils policy concerns for 2021; NRC seeks nominees for medical isotopes adcomm; Senators: More protection needed for genomic data; Veterans’ genomic data put at risk; DNA sequencing claims struck down.
The U.S. Department of Veterans Affairs (VA) is looking for more discounts from prescription drug manufacturers, but it likely will be a few years before the ask becomes reality as it will require congressional action and federal rulemaking.