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Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

Health equityDrug administrationOffice of clinicalOffice of women healthOffice of pediatric therapeuticsOncology centerOffice of minority healthRadiological healthGuidance issuing officeSubmit commentsBiologics evaluationDrug evaluationMinority healthClinical policyEthnicity data

Ethical, Regulatory, and Operational Considerations for Cell and Gene Therapy Research in Children

Ethical, Regulatory, and Operational Considerations for Cell and Gene Therapy Research in Children
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United statesRahul mirchandaniDonna snyderSanjay srivastavaNational institutes of healthSomatic gene therapy research in pediatric populationsRegulatory affairs certificateGuidelines for research involving recombinantInstitutional biosafety committeeAmerican society for geneInstitutional biosafety committee viceOffice of pediatric therapeuticsHarvard medical schoolClinical trial coGene therapyReview boards

Everything you need to know about artificial wombs

Artificial wombs are nearing human trials. But the goal is to save the littlest preemies, not replace the uterus.

United kingdomUnited statesBrady thomasMarcus daveyMark mercurioGeorge mychaliskaAlan flakeElizabeth chloe romanisVardit ravitskyDrug administrationExtrauterine environment for newborn developmentUniversity of michiganMit technology reviewYale school of medicineHastings centerUniversity of iowa stead family children hospital

Pediatric Advisory Committee Meeting Announcement

Pediatric Advisory Committee Meeting Announcement

United statesSilver springOffice of pediatric therapeuticsOffice of clinicalOffice of media affairsPediatric advisory committeeAdvisory committeeDrug administrationAdvisory committee meetingsAdvisory committee information lineCommittees giveNeonatal intensive carePediatric advisoryRulemaking portalSocial securityDockets management staff

FDA Roundup: October 28, 2022

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA updated the.

Barbara buchLynne yaoDivision of pediatricsCenters for diseaseFresenius medicalOffice of pediatric therapeuticsDrug administrationOffice of media affairsBreakthrough devices programMaternal healthFresenius medical careBreakthrough devicesBreakthrough deviceDevices programAdvance medicinesDionna green