FDA Unfazed By Brisk Pace Of In Vitro Diagnostics Class I Recalls
This article was originally published in The Silver Sheet
A SURGE IN CLASS I IN VITRO DIAGNOSTICS RECALLS has stakeholders debating the significance of the upswing. FDA sees evidence that IVD manufacturers have honed their corrective and preventive action programs, while a clinical lab association suspects the recalls may point to problems in IVD clinical trial design. FDA Office of In Vitro Diagnostics Director Gutman’s calm response to the Class I increase reflects his non-confrontational approach to compliance overall, though one industry attorney cautions against companies letting down their guard. Recalling firms are determining root causes and implementing corrective actions
You may also be interested in...
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.
Azar says ACIP’s prioritization recommendations should carry weight, but states will be final arbiter of who is vaccinated.
Sanofi R&D head John Reed says the company has kept 95% of patients on its nearly 400 clinical trials, started 59 studies, and benefited from its in-house drug supply management.