Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
OSHA Releases Scaled-Down Health Care Worker COVID-19 Protection Rule
The kinder, gentler version of the standard removes key controversial elements, such as mandating vaccination for employees.
CMS Delays Start of Radiation Oncology Model
The model, meant to start Jan. 1 of this year, had already been delayed over concerns from key stakeholders, and its start date is now TBD
More Time Needed to Evaluate VALID Act, AMP Urges Congress
Key stakeholders hold a briefing to inform lawmakers of the impact of potential new regulations for laboratory developed testing procedures.
White House: Great Progress in Health Care Coverage, but More Work to Be Done
The White House recently provided on update on agencies’ progress in carrying out EO to boost Medicaid and the Affordable Care Act
Biomarkers Found in Breast Milk Could Lead to Better Cancer Screening
Researchers from Clarkson University and the University of Massachusetts Amherst have discovered breast cancer biomarkers in breast milk that could eventually lead to a blood test for better screening for the disease in all risk and age groups, as the biomarkers...
Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization
On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the...
The Craze Is Over but Healthcare SPAC Deals Remain Alive and Well
A hot trend in capital raising for the healthcare and life sciences industries only two years ago, SPAC deals have petered out, but are far from dead.
Join Us April 27th to Discuss How We Can Improve Our Content
Webinar will give you the chance to learn about recent changes at G2 and ask the editorial team any questions you may have.
Congress Strikes Deal on COVID-19 Response Funding
The good news: Congressional negotiators have cut a deal for $10 billion in additional funding for COVID-19 testing and vaccination in the US. The bipartisan package will enable the federal government to purchase more therapeutics, tests, vaccines, and other...
Castle Biosciences Set to Acquire AltheaDx
In a key deal announced this week, Castle Biosciences signed a definitive agreement to acquire commercial-stage molecular diagnostics company AltheaDx, which specializes in pharmacogenomics testing services focused on mental health. In a statement released April 4,...
