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FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical Studies | Faegre Drinker Biddle & Reath LLP

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As...
Electronic Health Records Framework For Real World Evidence Program Faegre Drinker Biddle Reath Drug Administration Faegre Drinker Biddle Real World Data

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CNN New Day Weekend With Christi Paul and Boris Sanchez September 4, 2021 12:24:00

Regulators are going to be looking for. >> well, the studies in israel did not really compare directly people who got boosted to those who did not. it compared people who got boosted to themselves. so how did they do before and after they were boosted? and that study design is kind of weak. you always want to do something in parallel and realtime, because then you really know that the exposures were the same. and the other thing that we dont really have yet from the israeli data is a full readou...
Study Design Anthony Fauci

Biogen Inc.: New Data at Cure SMA 2021 Highlight the Long-Term Efficacy of SPINRAZA (nusinersen) and Biogen's Commitment to Innovation in SMA Therapy

New data analysis suggests an investigational higher dose of SPINRAZA may lead to clinically meaningful improvements in motor functionA NURTURE study analysis shows 92 percent of children who initiated
United States United Kingdom Mike Hencke Charles Weissmann Walter Gilbert Heinz Schaller

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