On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
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In a surprise move, the e-retail giant announced it will close down its Amazon Care Primary Health Services for employees at the end of 2022.
While the rule is not yet final, it’s likely that labs will have to pay more in direct CLIA compliance expenses, starting in October.
While not nearly as robust as a year ago, diagnostic companies’ revenues held up surprisingly well in Q2 2022.
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
In July, ICATT took a major step toward equitable access to testing by enlisting two of the country’s leading COVID-19 PCR test providers.
It’s beginning to look like Illumina’s roll of the dice is going to come up snake eyes regarding the potential acquisition.
The way the No Surprises Act is implemented would essentially allow private health plans to set out-of-network rates in billing disputes.
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Independent labs accrued a profit of at least $10 on each PCR COVID-19 test performed in the period from May to December 2020, study says.
Some of the lab industry’s biggest players are teaming up to develop new monkeypox diagnostics in response to the current outbreak.