Zobrazeno 1 - 10
of 98
pro vyhledávání: '"Jonathan J, Darrow"'
Publikováno v:
American journal of public health. 112(8)
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::067a62aff191450b2c74dd0473676e7f
https://pubmed.ncbi.nlm.nih.gov/35709409
https://pubmed.ncbi.nlm.nih.gov/35709409
Publikováno v:
Clinical and Translational Science, Vol 14, Iss 5, Pp 1917-1923 (2021)
Abstract Before the first generic version of a drug is marketed, patent litigation often occurs. The process begins when generic manufacturers notify the US Food and Drug Administration (FDA) of their intent to market a generic copy of a brand‐name
Externí odkaz:
https://doaj.org/article/444f8071a4ec4668999ba66d1443f2b9
Autor:
Tobias B. Polak, David G. J. Cucchi, Joost van Rosmalen, Carin A. Uyl-de Groot, Jonathan J. Darrow
Publikováno v:
Frontiers in Pharmacology, Vol 13 (2022)
Patients with rare diseases often have limited or no options for approved treatments or participation in clinical trials. In such cases, expanded access (or “compassionate use”) provides a potential means of accessing unapproved investigational m
Externí odkaz:
https://doaj.org/article/8bbc06b9ca294fc1a327ee1a439bb5c2
Publikováno v:
BMJ Open, Vol 12, Iss 4 (2022)
Objectives To evaluate the incremental value of new drugs across disease areas receiving favourable coverage decisions by the UK’s National Institute for Health and Care Excellence (NICE) over the past decade.Design, setting, and participants This
Externí odkaz:
https://doaj.org/article/7db24d5d0d564c3a8802ddbff4096b98
Publikováno v:
Journal of Global Oncology, Vol 5, Pp 1-17 (2019)
PURPOSE: The population of Chile has aged, and in 2017, cancer became the leading cause of death. Since 2005, a national health program has expanded coverage of drugs for 13 types of cancer and related palliative care. We describe the trends in publi
Externí odkaz:
https://doaj.org/article/8252bd322bd74a14824fecee8182b544
Publikováno v:
Nature Communications, Vol 10, Iss 1, Pp 1-10 (2019)
Non-traditional antibacterial agents are challenging to develop. In this Perspective, the authors argue that the distinction between traditional and non-traditional agents has only limited relevance for regulatory purposes, although products with non
Externí odkaz:
https://doaj.org/article/3146f09e95be41bd9cb39854de101287
Autor:
Beatrice L. Brown, Mayookha Mitra-Majumdar, Jonathan J. Darrow, Osman Moneer, Catherine Pham, Jerry Avorn, Aaron S. Kesselheim
Publikováno v:
JAMA internal medicine.
This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2adbe0ab11b75e44e574dada16383af5
https://pubmed.ncbi.nlm.nih.gov/36190713
https://pubmed.ncbi.nlm.nih.gov/36190713
Publikováno v:
The Lancet Diabetes & Endocrinology. 11:73-75
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e5839447a56afd47f374eb3104c97387
https://doi.org/10.1016/s2213-8587(22)00354-0
https://doi.org/10.1016/s2213-8587(22)00354-0
Autor:
Sanket S. Dhruva, Aaron S. Kesselheim, Steven Woloshin, Robin Z. Ji, Zhigang Lu, Jonathan J. Darrow, Rita F. Redberg
Publikováno v:
Clinical Pharmacology & Therapeutics.
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::b1e112e8682fcd188b07b278c6ccd7de
https://doi.org/10.1002/cpt.2954
https://doi.org/10.1002/cpt.2954
Publikováno v:
Journal of Health Politics, Policy and Law.
Since 2004, the Food and Drug Administration (FDA) has had the authority to allow access to unapproved medical products via the Emergency Use Authorization (EUA) pathway during times of emergency. It was rarely used until the COVID-19 pandemic, when
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::e2f25c73d8e71926ef762a8fa8a975e7
https://doi.org/10.1215/03616878-10637726
https://doi.org/10.1215/03616878-10637726