Life Sciences News and Resources
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December 14, 2022
In this year’s annual year-end wrap-up, a panel including Andy Hall and Lauren Hulbert with Medmarc’s claims department, as well as Jennifer Heis, an attorney with Ulmer Berne, will provide a claims...
December 1, 2022
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter than Health...
November 9, 2022
The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...
October 26, 2022
The new FDA final guidance for post-approval studies (PAS) accelerates some of the timelines in the previous version, and introduces some new deadlines to this policy. These changes are the same as...
October 25, 2022
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types of...
