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Pierre Fabre Laboratories Announce IND Filing for PFL-002/VERT-002, a Potential Treatment for...
KETK· 1 day agoFood and Drug Administration ("FDA") to initiate a first-in-human (FIH) Phase I/II clinical trial with PFL-002/VERT-002 for solid tumors including non-small cell lung cancer ...
Settlement Roundup: Heart-Valve Replacements, Federal Research Grants, and Clinical Laboratory...
JD Supra· 1 day agoThe Department of Justice (DOJ) recently announced settlements involving alleged noncompliance with Medicare billing requirements for heart-valve...
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 3 days agoDistrict Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests ...
JD Supra: FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests
JD Supra· 17 hours agoFDA published a four-year enforcement discretion phaseout plan as part of its implementation of the Final Rule. The agency offered exemptions from some regulatory requirements for tests and ...
Nanoparticles: Risk for babies in the womb | Newswise
Newswise· 5 hours agoTina Bürki and her team from Empa's Particles-Biology Interactions laboratory in St. Gallen are...
MEDIA ADVISORY - Webinar: The U.S. FDA’s rule on | Newswise
Newswise· 3 days agoThe U.S. Food and Drug Administration (FDA) has long sparked controversy with its proposals to regulate laboratory developed tests (LDTs) as medical device
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 7 days agoRather, LDTs are federally regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments ...
Allstate Fraud Claim Over Urine Drug Tests Can Proceed Against Laboratory | New Jersey Law Journal
Law.com· 6 days agoIn a qui tam action filed by Allstate Insurance, the court denied a clinical laboratory’s motion to...
Experts alert doctors and the public to the arrival of hard-to-treat fungal skin infections in the...
Medical Xpress· 19 hours agoIn the first of the studies, experts at NYU Langone Health who focus on the spread of contagious...
Rockford-area blood supply reaches critical low
WIFR Rockford· 7 hours agoThe Rock River Valley Blood Center faces a severe shortage of blood and medical experts say this puts patients at risk. Heidi Ognibene, RRVBC’s chief...
