FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.