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The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics

FDA has launched a Real World Evidence (RWE) Program for using real-world evidence (RWE) to help support new indications for already approved drugs or biologics and postapproval studies. The plan also includes stakeholder engagement efforts, demonstration projects, leadership activities, and develop...

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Dettagli Bibliografici
Pubblicato in:J Diabetes Sci Technol
Autore principale: Klonoff, David C.
Natura: Artigo
Lingua:Inglês
Pubblicazione: SAGE Publications 2019
Soggetti:
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC7196856/
https://ncbi.nlm.nih.gov/pubmed/30862182
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1932296819832661
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