FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Lab Compliance Advisor
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Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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
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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
OIG Monthly Work Plan Review: March 2019
From - Lab Compliance Advisor
This month, there were 16 new Work Plan items. Three of these may have implications for some labs as…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
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Brief Your CEO: Notify Your Lab Execs of Upcoming Stark Law Changes
From - Lab Compliance Advisor
One of the best ways to score points with your lab's executives is to warn them about legal changes before they happen and…
Three key items to negotiate for successful payer contracts
By Steve Selbst bio
The purpose of this article is to help you, as a provider, to focus on three key items to look for in payer contracts that will help you to get profitable contracts in place…
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