Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
- Healthcare-related laws
- FDA approvals
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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
Analytic Systems Account for 5 of Top 10 Most Cited CLIA Deficiencies
CMS has published its list of top 10 most frequently cited Clinical Laboratory Improvement Amendments deficiencies for the previous year.
FDA Getting More Muscle to Take Unproven AA Drugs Off the Market
Created in 1982 in response to the HIV/AIDS epidemic, the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) Program provides for expedited approval of novel treatments of serious health conditions that the current market isn’t adequately...
How to Protect Your Lab against Most Common Cyberattacks
According to the U.S. Department of Health & Human Services’ (HHS) Office for Civil Rights (OCR), the number of cyberattacks against the health care industry has increased in recent years. Specifically, hackers are...
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
Partnership to Create New Tool for Rapid SARS-CoV-2 Variant Detection
Thermo Fisher, Helix, and Rosalind collaborate on an NIH-supported project to develop a new genotyping method to ID virus variants faster.
The Government Is Running Out of Money for COVID-19 Testing
The White House recently wrote that without restoring COVID-19 funding, the country won’t be able to buy enough supplies to combat the virus.
Ellume Faces Class Action Lawsuit Over At-Home COVID-19 Test Kits
Back in October and November, Ellume voluntarily recalled two separate lots of its Rapid Antigen At-Home COVID-19 Test Kits due to the risk of providing false positive results. The U.S. Food & Drug Administration classed the November recall as Class I, the most...
Illumina Wins Decisive Victory in Patent Infringement Case Against BGI
After prevailing in its patent infringement lawsuit against BGI Genomics, Illumina cemented its victory by getting a permanent injunction barring the Chinese sequencing firm and its subsidiaries, including MGI Tech, from selling its sequencers and reagents in the...
Labs in Court Weekly Roundup
In enforcement actions involving the health care industry listed by the U.S. Department of Justice (DOJ) from March 22 to March 25, most cases involved billing for services that were never provided, as well as a more elaborate scheme involving a fake housing...