Policy & Legislation
News on government policy and legislation impacting the life science and diagnostics markets.
All of Us Program Looking to Public-Private Partnerships, Other Funding Amid Budget Uncertainty
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In a report, a working group cautioned that the program must lessen its reliance on congressional appropriations or risk "squandering" investments made so far.
New Billing Code for Genetic Counselors Will Better Capture Time Spent on Patients, NSGC Says
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At its annual meeting, NSGC also said the new code will further the organization's goal of securing better reimbursement for genetic counselors.
House Passes Biosecure Act With Bipartisan Support
The torch to sanction certain targeted Chinese biotech firms is now passed to the Senate, which does not yet have a clear timeline for the vote.
FDA Issues Draft Guidance on Process for Modifying Medical Devices Including Lab Tests
The guidance covers predetermined change control plans, which some in the lab industry are looking to for flexibility following FDA's recent rule on lab-developed tests.
AMP Sues FDA Over Laboratory-Developed Test Final Rule
Filed in the US District Court for the Southern District of Texas, the lawsuit is the second legal challenge to the rule following a suit filed by ACLA in June.