Výsledky vyhledávání - "Andrea N. Monge"

Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021

Autor: Andrea N. Monge, Daniel W. Sigelman, Robert J. Temple, Harinder Singh Chahal

Publikováno v: JAMA network open. 5(11)

ImportanceThe US Food and Drug Administration (FDA) has 4 programs that can be used alone or in combination to expedite drug availability: Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review. Drugs using these programs can inc

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::42bc84d99c48db3a3c94f364cb7724ce
https://pubmed.ncbi.nlm.nih.gov/36318213

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