Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine

Lada Leyens; Etienne Richer; Oyvind Melien; Wolfgang Ballensiefen; Angela Brand

doi:10.1159/000437137

Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine

Lada Leyens^*, Etienne Richer, Oyvind Melien, Wolfgang Ballensiefen, Angela Brand

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

9 Citations (Web of Science)

Original language	English
Pages (from-to)	249-259
Journal	Public Health Genomics
Volume	18
Issue number	5
DOIs	https://doi.org/10.1159/000437137
Publication status	Published - 2015

Keywords

Early patient access
Conditional approval
Accelerated approval
Personalized medicine
Drug development
Regulation
European Medicines Agency
Food and Drug Administration
Health technology assessment

Access to Document

10.1159/000437137

Cite this

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title = "Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine",

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language = "English",

volume = "18",

pages = "249--259",

journal = "Public Health Genomics",

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Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine. / Leyens, Lada; Richer, Etienne; Melien, Oyvind; Ballensiefen, Wolfgang; Brand, Angela.

In: Public Health Genomics, Vol. 18, No. 5, 2015, p. 249-259.

Research output: Contribution to journal › Article › Academic › peer-review

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T1 - Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine

AU - Leyens, Lada

AU - Richer, Etienne

AU - Melien, Oyvind

AU - Ballensiefen, Wolfgang

AU - Brand, Angela

PY - 2015

Y1 - 2015

KW - Early patient access

KW - Conditional approval

KW - Accelerated approval

KW - Personalized medicine

KW - Drug development

KW - Regulation

KW - European Medicines Agency

KW - Food and Drug Administration

KW - Health technology assessment

U2 - 10.1159/000437137

DO - 10.1159/000437137

M3 - Article

C2 - 26316202

VL - 18

SP - 249

EP - 259

JO - Public Health Genomics

JF - Public Health Genomics

SN - 1662-4246

IS - 5

ER -