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ARUP Files Declaration to Support Lawsuit Challenging the FDA's Rule to Regulate Lab-Developed Tests
ThePress.net· 6 days agoARUP Laboratories is backing a federal lawsuit filed by the American Clinical Laboratory Association (ACLA) challenging the FDA's final rule to regulate ...
Aurigene Pharmaceutical opens biologics facility in Hyderabad, India
Pharmaceutical Technology via Yahoo Finance· 5 days agoThe process and analytical development laboratories at the facility are already operational, and the...
Settlement Roundup: Heart-Valve Replacements, Federal Research Grants, and Clinical Laboratory...
JD Supra· 4 days agoThe Department of Justice (DOJ) recently announced settlements involving alleged noncompliance with Medicare billing requirements for heart-valve...
Next Gen Diagnostics CEO Paul Rhodes Announces That Dr. Linoj Samuel Has Joined NGD’s Scientific...
Digital Journal· 1 day agoSamuel. "I welcome the opportunity to contribute clinical and operational perspective and experience to NGD's development of services that leverage the ...
Florida Pony Mare Positive For Contagious Equine Metritis
Paulick Report· 5 days agoOn May 23, 2024, the National Veterinary Services Laboratories (NVSL) reported a confirmed case of Contagious Equine Metritis (CEM) in an 11-year-old pony mare based in Orange ...
Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests | JD Supra
JD Supra· 6 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 ...
First salvo fired against FDA’s laboratory developed test rule | JD Supra
JD Supra· 3 days agoHealthTrackRx’s complaint claims Congress has never granted FDA the authority to regulate LDTs, and that they instead have been properly regulated by the Centers for Medicare and Medicaid < ...
Laboratory Association Sues FDA Over its Recent Laboratory-Developed Test Final Rule | JD Supra
JD Supra· 3 days agoThis overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments ...
Charles River Laboratories International (NYSE:CRL) Upgraded to “Buy” by StockNews.com
ETF DAILY NEWS· 23 hours agoCitigroup raised their price objective on shares of Charles River Laboratories International from $215.00 to $250.00 and gave the stock a “neutral” rating in a research note on Thursday, February ...
JD Supra: FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests
JD Supra· 3 days 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 ...