Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

Drug Labeling Drug Prescriptions Humans Neoplasms / drug therapy Pharmaceutical Preparations Pilot Projects United States United States Food and Drug Administration
Cancer Drug approval Drug legislation Drug prescriptions Pharmaceutical research

Journal

The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837

Informations de publication

Date de publication:
03 2020
Historique:
received: 11 09 2019
accepted: 04 10 2019
entrez: 13 3 2020
pubmed: 13 3 2020
medline: 22 6 2021
Statut: ppublish

Résumé

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.

Identifiants

DOI: 10.1634/theoncologist.2019-0698 PMID: 32162805 PMC: PMC7066705
pubmed: 32162805
doi: 10.1634/theoncologist.2019-0698
pmc: PMC7066705
doi:

Substances chimiques

Pharmaceutical Preparations 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

e405-e411

Informations de copyright

© 2019 The Authors. The Oncologist published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

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pubmed: 28968170
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pubmed: 30834049
Ther Innov Regul Sci. 2018 Nov;52(6):771-777
pubmed: 29714570
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pubmed: 29214638
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pubmed: 6396792
J Natl Cancer Inst. 2010 Sep 8;102(17):1371
pubmed: 20682918
JCO Clin Cancer Inform. 2019 Jul;3:1-15
pubmed: 31335166

Auteurs

Erin P Balogh (EP)

Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA.
ORCID: 0000-0001-7272-1622

Andrew B Bindman (AB)

University of California, San Francisco, California, USA.

S Gail Eckhardt (SG)

University of Texas at Austin's Dell Medical School, Austin, Texas, USA.

Susan Halabi (S)

Duke University, Durham, North Carolina, USA.

R Donald Harvey (RD)

Emory University, Atlanta, Georgia, USA.

Ishmael Jaiyesimi (I)

Beaumont Hospital, Royal Oak, Michigan, USA.

Rebecca Miksad (R)

Flatiron Health, New York, New York, USA.

Harold L Moses (HL)

Vanderbilt University, Nashville, Tennessee, USA.

Sharyl J Nass (SJ)

Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine, Washington, DC, USA.

Richard L Schilsky (RL)

American Society of Clinical Oncology, Alexandria, Virginia, USA.

Steven Sun (S)

Janssen Research and Development, Raritan, New Jersey, USA.

Josephine M Torrente (JM)

Hyman, Phelps & McNamara, P.C., Washington, DC, USA.

Katherine E Warren (KE)

Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.

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Classifications MeSH

questionsmedicales.fr › Technologie, industrie et agriculture › Industrie › Emballage de produit › Emballage de médicament › Étiquetage de médicament › Challenges and Opportunities to Updating...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Services pharmaceutiques › Ordonnances › Ordonnances médicamenteuses › Challenges and Opportunities to Updating...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Challenges and Opportunities to Updating...
questionsmedicales.fr › Tumeurs › Challenges and Opportunities to Updating...
questionsmedicales.fr › Préparations pharmaceutiques › Challenges and Opportunities to Updating...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Projets pilotes › Challenges and Opportunities to Updating...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Challenges and Opportunities to Updating...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › Challenges and Opportunities to Updating...