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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
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Radiopharmaceutical Gets FDA Approval for Treatment of Prostate Cancer
Patients with metastatic castration-resistant prostate cancer now have a new treatment option with the U.S. Food and Drug Administration’s (FDA’s) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The radiopharmaceutical medication, from Novartis...
Global Aspiration & Biopsy Needles Market to See Strong Growth
According to a recent report, this market will see almost seven percent annual growth over the next five years, reaching US $1.29 billion in 2026.
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.