FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Essential
Subscribe today for access to
Articles and Reports
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Dx Deals: BD Laboratory Business Is Up for Grabs in Bold Move
Becton Dickinson divisions responsible for $3.4 billion in annual revenue are on the block
HHS’ Top Ten Management Problems Include Labs
...
Already a member? Log in here
ACMG Issues Position Statement on Direct-to- Consumer Tests
...
Already a member? Log in here
Congress Lobbies CMS on PAMA Regulations
...
Already a member? Log in here
FDA Looks Back at Successes and Details Plans for 2016, Including LDTs
...
Already a member? Log in here
Pathway Genomics Denies Wrongdoing, Settles False Claims Allegations for $4 Million
From - G2 Compliance Advisor
As the year came to a close, the Federal Bureau of Investigation and the U.S. Attorney's Office announced December 30, 2015, a $4 million settlement with Pathway Genomics. The San Diego-based laboratory denied wrongdoing but agreed to pay that sum to resolve…
NeoGenomics Completes Clarient Acquisition
From - Laboratory Industry Report
Florida-based NeoGenomics has completed its acquisition of the Clarient Diagnostics unit from GE Healthcare. Clarient provides cancer diagnostics to hospitals, physicians, and drug companies…
CDC Year in Review and Future Plans Include Laboratory Safety
From - G2 Compliance Advisor
Laboratory safety and diagnosis of infections figure prominently in the Centers for Disease Control and Prevention's (CDC) review of 2015 and its agenda for 2016. The agency's Year in Review highlighted "the most pressing public health challenges of…
News at a Glance – Jan 2016
...
Already a member? Log in here
Diagnostics Data Analytics Inform Treatment, Utilization, Safety & Quality
...
Already a member? Log in here
Top 10 Compliance Issues and Tips for 2016
...
Already a member? Log in here