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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
Balwani Lawyers: Elizabeth Holmes Entirely to Blame for Theranos
"Elizabeth Holmes, not Sunny, founded Theranos and built Theranos." So spoke defense counsel Steve Cazares in his opening statement in the trial of Theranos co-founder Ramesh “Sunny” Balwani, which resumed earlier this week. Pointing the finger at the other partner...
FDA Releases Latest List of Authorized At-Home OTC COVID-19 Tests
With coverage of over-the-counter (OTC) COVID-19 tests set to expand to include those covered by Medicare, the U.S. Food and Drug Administration (FDA) recently released its most up-to-date list of authorized at-home test kits for the SARS-CoV-2 virus that causes...
What’s New with G2? Brand Update and Q&A Session
Get an update on G2 Intelligence, learn what key lab industry stories our editors are following, and ask any questions you may have.
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.