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FDA seeks AI tech to predict, detect Parkinson’s symptoms
MedTech Dive via Yahoo Finance· 15 hours agoBy testing artificial intelligence and machine learning models, the agency hopes to come up with...
FDA greenlights SAB Biotherapeutics' diabetes drug trial By Investing.com
Investing.com· 10 hours agoThe U.S. Food and Drug Administration (FDA) has cleared SAB Biotherapeutics' investigational new...
GC Biopharma/Novel Pharma's Sanfilippo Syndrome Treatment Obtains FDA IND Clearance
NBC 17 Raleigh· 19 hours agoKS) and Novel Pharma have announced that the U.S. FDA has cleared the investigational new drug (IND) application for their jointly developed MPSIIIA (Sanfilippo Syndrome Type ...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements | JD Supra
JD Supra· 19 hours agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed ...
Larimar's Friedreich's ataxia program free at last from FDA hold
FierceBiotech· 13 hours agoLarimar Therapeutics’ Friedreich’s ataxia program is free at last, with the FDA fully lifting a...
FDA clears Neuralink chip for 2nd human trial, company says wire issue fixed
Homenewshere.com· 1 day agoThe FDA gave Neuralink approval to implant its chip in a second human patient after it updated...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 19 hours agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration ...
Mass. medical device company agrees to plead guilty, pay $42M to resolve criminal charges
WCVB Boston· 2 hours agoA medical device company headquartered in Massachusetts has agreed to resolve criminal charges...
FDA grants IND clearance for Drug Farm’s ROSAH syndrome trial
Clinical Trials Arena via Yahoo Finance· 2 days agoThe US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application...
Trump says he is open to restrictions on contraception before backing away from the statement
San Francisco Chronicle· 2 hours agoFormer President Donald Trump on Tuesday said he was open to supporting regulations on contraception...