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Unpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance | Epstein Becker & Green

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket.

United statesDrug administration amendments actDrug administrationEpstein beckerClinical trials registrationResults information submissionFinal ruleApplicable clinical trialEvaluating whetherClinical trialInvestigational device exemptionStudy typePrimary purposeDevice productFacility locationProduct manufactured

Minority enrollment still low in ophthalmic clinical trials after Final Rule implemented

Minority enrollment still low in ophthalmic clinical trials after Final Rule implemented
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Human servicesDepartment of healthFinal ruleReal worldClinical trials registrationResults information submission

Quack stem cell clinics: Following the trail blazed by Stanislaw Burzynski charging patients to be on dubious clinical trials

A new study by Leigh Turner has found that dubious stem cell clinics are registering even more dubious "clinical trials" under ClinicalTrials.gov in which they charge patients to enroll. In this unethical practice, they are merely following the trail blazed by cancer quack Stanislaw Burzynski.

United statesPaul knopflerBurzynski clinicLeigh turnerClinica santa claritaGordie howeStanislaw burzynskiAgeless regenerative instituteLung instituteNational cancer instituteNational institutes of healthSchool of public healthUniversity of minnesota centerHuman services office for research protectionsWashington postDepartment of health