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FDA Announces AI Regulatory Intentions, Following EU AI Act

FDA Announces AI Regulatory Intentions, Following EU AI Act
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United kingdomUnited statesSouth koreaOffice of combination productsDevice software functionsRisk management for agencyFoster collaboration to safeguard public healthCoalition for healthOpportunities for agency engagementQm centerDrug administrationRegulatory agencyRadiological healthOffice of managementDevelopment of standardsHealth canada

FDA Issues Draft Guidance On Using RWE In Medical Device Submissions - Life Sciences, Biotechnology & Nanotechnology

New draft guidance describes factors for determining when evidence generated from real-world data may be used to support FDA decisions on medical devices .

Drug administrationReal world evidenceSupport regulatory decision makingFda issues draft guidance on using rwe in medical device submissionsLife sciencesFood and drugs lawLife sciencesIotechnology amp nanotechnology

Health Care Week in Review: Biden Administration Issued Final Rule on Fees for IDR Process Under NSA; W&M Democrats Release Report on Health Care System s Role in Climate Crisis | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and.

Department of healthCommittee democratsBiden administrationNational advisory child healthScientist proposed guidance development listRanking member of the senate healthNational cancer institute clinical trialsCompliance teamDrug administrationHuman servicesBlood institute sickle cell disease advisory committeeMeans committee democratsClinical laboratory improvement amendmentsMental health services administrationOffice of inspectorCenters for medicare medicaid services

Realizing the Promise of Real-World Evidence

Realizing the full potential of RWE in regulatory decision-making presents several challenges, and work is underway at the FDA to better understand this area.

Robertm califfHuman servicesInformation technology strategyUs healthReal world evidenceSupport regulatory decision makingMedical devicesWorld dataAssessing registriesBiological productsTechnology strategy

FDA Roundup: December 19, 2023

FDA Roundup: December 19, 2023
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Brian kingAstellas pharmaApp to fitbitCodex alimentarius commissionOffice of media affairsCounter monograph drug user fee programEuropean medicines agencyBody temperature softwareDrug administrationAutogenomics incKnow your treatment optionsCosmetics directCosmetics regulation actTobacco productsDirector brian kingPrescription drug user fee act