Despite New Hires, Personnel Challenges Remain For FDA
The good news for the FDA is the agency has already hired 2,000 new employees this year; the bad news is they still have 2,000 more to go. FDA chief of staff Julie Tierney discussed some of the agency’s hiring successes and challenges during a recent Alliance for a Stronger FDA webinar.
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During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.
News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’
This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.
Four More Guidance Documents Released: Antimicrobial Devices, Closed-Loop Control Technology, De Novo Submissions, Devices For Graft Versus Host Diseases
The US FDA recently published four guidance documents, two final — one concerning antimicrobial susceptibility test system devices and another related to devices with physiologic closed-loop control technology. The agency’s two draft documents pertain to electronic submissions for de novo requests and graft-versus-host diseases.