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A Proposed Framework for Patient-Focused Policy at the U.S. Food and Drug Administration

Medical product sponsors are encouraged to include the patient perspective in their medical product development strategy to inform product design, augment regulatory submissions, argue for alternative clinical trial designs, or to support indications in specific patient populations. The goal is to c...

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Detaylı Bibliyografya
Yayımlandı:Biomedicines
Yazar: Kuehn, Carrie M.
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: MDPI 2019
Konular:
Online Erişim:https://ncbi.nlm.nih.gov/pmc/articles/PMC6784212/
https://ncbi.nlm.nih.gov/pubmed/31461892
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3390/biomedicines7030064
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