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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 States , Drug Administration Amendments Act , Drug Administration , Epstein Becker , Clinical Trials Registration , Results Information Submission , Final Rule , Applicable Clinical Trial , Evaluating Whether , Clinical Trial , Investigational Device Exemption , Study Type , Primary Purpose , Device Product , Facility Location , Product 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 Services , Department Of Health , Final Rule , Real World , Clinical Trials Registration , Results 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 States , Paul Knopfler , Burzynski Clinic , Leigh Turner , Clinica Santa Clarita , Gordie Howe , Stanislaw Burzynski , Ageless Regenerative Institute , Lung Institute , National Cancer Institute , National Institutes Of Health , School Of Public Health , University Of Minnesota Center , Human Services Office For Research Protections , Washington Post , Department Of Health , Bioheart Inc , National Institutes , Public Health , Texas Medical Board , New England Journal , Acuity Measurements , Human Services Office , Human Research Protections , Investigational New Drug , Investigational Device Exemption ,