FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Pre-submission and Q-Submission meetings apparently have been halted, for now
Though only seven transactions were announced or closed in November, two were billion-dollar deals.
Key cases over the past month were the usual FCA-related fare, apart from a dismissed sex discrimination case.
It’s important to have a clear policy in place for approving remote work requests and ensuring employees remain productive.
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
Could not following MAC guidance constitute evidence that a party knowingly submitted, or caused the submission of, false claims?
There are potentially significant legal ramifications of employing digital nomads who work from abroad—for both you and your employee.
What labs and billing managers need to know about multianalyte assays with algorithmic analyses coding for tests based on molecular platforms.
The court recently denied the petition to hear a case that would have helped offer clarity on what evidence whistleblowers need to file qui tam lawsuits under the FCA.
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
With temporary waivers of restriction relating to telehealth likely to end soon, here’s a roundup of the current state of state telehealth licensing law.