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New Manuscript Examines FDA's Use OF RWE In Drug Approvals


New Manuscript Examines FDA s Use OF RWE In Drug Approvals
By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
The FDA review process for new drugs has transformed over recent years, resulting in faster and more efficient approvals. One aspect of that transformation is the use of real-world evidence (RWE) to complement clinical-trial evidence. The introduction of the 21
st Century Cures Act in 2016 has increased interest in the potential use of RWE in new drug approvals, but little has been shared on how the FDA is 
actually using RWE in their reviews.
Value in Health and hopes to share insights on that FDA process. The manuscript reviews five recent examples where RWE was submitted in support of the FDA approvals of original or supplementary indications for oncology drugs. The study found that, by bridging the gap between the constraints of the clinical trial setting and the realities of clinical practice, RWE can add value to ....

Ed Miseta , Bruce Feinberg , Cardinal Health Speciality Solutions , Cardinal Health , Chief Editor , Century Cures Act , Real World Evidence , காயங்கள் ஃபைன்பெர்க் , கார்டினல் ஆரோக்கியம் சிறப்பு தீர்வுகள் , கார்டினல் ஆரோக்கியம் , தலைமை ஆசிரியர் , சிஇஎன்டியுவ்ஆர்ஒய் குணப்படுத்துகிறது நாடகம் , ரியல் உலகம் ஆதாரம் ,