Zobrazeno 1 - 10
of 16
pro vyhledávání: '"Beatrice L. Brown"'
Publikováno v:
PLoS Medicine, Vol 20, Iss 3 (2023)
In an analysis of risk evaluation and mitigation strategies for teratogenic drugs, Ameet Sarpatwari, Beatrice Brown and Aaron Kesselheim explore the variation in primary and secondary prevention measures.
Externí odkaz:
https://doaj.org/article/1b7aee94255144668306a2212e2673f2
Publikováno v:
BMJ Medicine, Vol 1, Iss 1 (2022)
Objective To review the clinical evidence, regulatory background, and cost of antibiotics approved by the US Food and Drug Administration (FDA), 2016-19.Design Cohort study of FDA approved drugs.Data sources FDA databases, ClinicalTrials.gov, and dru
Externí odkaz:
https://doaj.org/article/a7181d4365d84785940a8e01489311f2
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
Autor:
Osman Moneer, Beatrice L. Brown, Jerry Avorn, Jonathan J. Darrow, Mayookha Mitra-Majumdar, Krysten W. Joyce, Murray Ross, Catherine Pham, Aaron S. Kesselheim
Publikováno v:
Drug Safety. 45:305-318
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::528aeb519402b4f84195609dab874b12
https://doi.org/10.1007/s40264-022-01152-9
https://doi.org/10.1007/s40264-022-01152-9
Autor:
Beatrice L. Brown, Mayookha Mitra-Majumdar, Krysten Joyce, Murray Ross, Catherine Pham, Jonathan J. Darrow, Jerry Avorn, Aaron S. Kesselheim
Publikováno v:
Journal of health politics, policy and law.
Context: New drug approvals in the United States must be supported by substantial evidence from “adequate and well-controlled” trials. The Food and Drug Administration (FDA) has flexibility in how it applies this standard. Methods: The authors co
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ed0a334dd12b4e896b1984e0cd8f0085
https://pubmed.ncbi.nlm.nih.gov/35867548
https://pubmed.ncbi.nlm.nih.gov/35867548
Autor:
Beatrice L. Brown, Mayookha Mitra-Majumdar, Osman Moneer, Jerry Avorn, ChangWon C. Lee, Aaron S. Kesselheim, Martin Kulldorff, Jonathan J. Darrow
Publikováno v:
Health Affairs. 40:25-32
The Food and Drug Administration generally approves vaccines when their benefits outweigh their risks for their intended use. In this paper, we review current and potential approaches to this criti...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::2e6ddca906efe9a9ccb4de2f30aa2903
https://doi.org/10.1377/hlthaff.2020.01620
https://doi.org/10.1377/hlthaff.2020.01620
Publikováno v:
BMJ Medicine. 1:e000227
ObjectiveTo review the clinical evidence, regulatory background, and cost of antibiotics approved by the US Food and Drug Administration (FDA), 2016-19.DesignCohort study of FDA approved drugs.Data sourcesFDA databases, ClinicalTrials.gov, and drug l
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::592b524a444b9b3ad4ca31a415a06f51
https://doi.org/10.1136/bmjmed-2022-000227
https://doi.org/10.1136/bmjmed-2022-000227
Autor:
Beatrice L. Brown, Aaron S. Kesselheim
Publikováno v:
AMA journal of ethics. 23(9)
The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device ri
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9f7a9c9cabc7e3851160d8eeb347619a
https://pubmed.ncbi.nlm.nih.gov/34710025
https://pubmed.ncbi.nlm.nih.gov/34710025
Autor:
Aaron S, Kesselheim, Jonathan J, Darrow, Martin, Kulldorff, Beatrice L, Brown, Mayookha, Mitra-Majumdar, ChangWon C, Lee, Osman, Moneer, Jerry, Avorn
Publikováno v:
Health affairs (Project Hope). 40(1)
The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh the risks for their intended use. In this article we review the standard FDA approach to vaccine evaluation, which underpins its current approaches to assessment of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::2253d04c68922ee115ea3091fe74b4a0
https://pubmed.ncbi.nlm.nih.gov/33211535
https://pubmed.ncbi.nlm.nih.gov/33211535
Autor:
Ameet, Sarpatwari, Beatrice L, Brown, Sarah A, McGraw, Sara Z, Dejene, Abdurrahman, Abdurrob, Adrian J, Santiago Ortiz, Aaron S, Kesselheim
Publikováno v:
JAMA Network Open
This qualitative study examines patient and caregiver experiences with and perceptions of Risk Evaluation and Mitigation Strategy programs with Elements to Assure Safe Use.
Key Points Question How do patients and caregivers describe their experi
Key Points Question How do patients and caregivers describe their experi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1250ad2afc3a43aecf72801eedf9457f
https://doi.org/10.1001/jamanetworkopen.2021.44386
https://doi.org/10.1001/jamanetworkopen.2021.44386