The future of population-based postmarket drug risk assessment: A regulator's perspective

T. A. Hammad, G. A. Neyarapally, S. Iyasu, J. A. Staffa, G. Dal Pan

Research output: Contribution to journalArticle

Abstract

The US Food and Drug Administration emphasizes the role of regulatory science in the fulfillment of its mission to promote and protect public health and foster innovation. With respect to the evaluation of drug effects in the real world, regulatory science plays an important role in drug risk assessment and management. This article discusses opportunities and challenges with population-based drug risk assessment as well as related regulatory science knowledge gaps in the following areas: (i) population-based data sources and methods to evaluate drug safety issues; (ii) evidence-based thresholds to account for uncertainty in postmarket data; (iii) approaches to optimize the integration and interpretation of evidence from different sources; and (iv) approaches to evaluate the real-world impact of regulatory decisions. Regulators should continue the ongoing dialogue with multiple stakeholders to strengthen regulatory safety science and address these and other critical knowledge gaps.

Original languageEnglish (US)
Pages (from-to)349-358
Number of pages10
JournalClinical Pharmacology and Therapeutics
Volume94
Issue number3
DOIs
StatePublished - Sep 2013
Externally publishedYes

Fingerprint

Pharmaceutical Preparations
Population
Safety
Drug Evaluation
Information Storage and Retrieval
Risk Management
United States Food and Drug Administration
Uncertainty
Public Health

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Medicine(all)

Cite this

The future of population-based postmarket drug risk assessment : A regulator's perspective. / Hammad, T. A.; Neyarapally, G. A.; Iyasu, S.; Staffa, J. A.; Dal Pan, G.

In: Clinical Pharmacology and Therapeutics, Vol. 94, No. 3, 09.2013, p. 349-358.

Research output: Contribution to journalArticle

Hammad, T. A. ; Neyarapally, G. A. ; Iyasu, S. ; Staffa, J. A. ; Dal Pan, G. / The future of population-based postmarket drug risk assessment : A regulator's perspective. In: Clinical Pharmacology and Therapeutics. 2013 ; Vol. 94, No. 3. pp. 349-358.
@article{d1561d09788046179a62eb7a66f8f173,
title = "The future of population-based postmarket drug risk assessment: A regulator's perspective",
abstract = "The US Food and Drug Administration emphasizes the role of regulatory science in the fulfillment of its mission to promote and protect public health and foster innovation. With respect to the evaluation of drug effects in the real world, regulatory science plays an important role in drug risk assessment and management. This article discusses opportunities and challenges with population-based drug risk assessment as well as related regulatory science knowledge gaps in the following areas: (i) population-based data sources and methods to evaluate drug safety issues; (ii) evidence-based thresholds to account for uncertainty in postmarket data; (iii) approaches to optimize the integration and interpretation of evidence from different sources; and (iv) approaches to evaluate the real-world impact of regulatory decisions. Regulators should continue the ongoing dialogue with multiple stakeholders to strengthen regulatory safety science and address these and other critical knowledge gaps.",
author = "Hammad, {T. A.} and Neyarapally, {G. A.} and S. Iyasu and Staffa, {J. A.} and {Dal Pan}, G.",
year = "2013",
month = "9",
doi = "10.1038/clpt.2013.118",
language = "English (US)",
volume = "94",
pages = "349--358",
journal = "Clinical Pharmacology and Therapeutics",
issn = "0009-9236",
publisher = "Nature Publishing Group",
number = "3",

}

TY - JOUR

T1 - The future of population-based postmarket drug risk assessment

T2 - A regulator's perspective

AU - Hammad, T. A.

AU - Neyarapally, G. A.

AU - Iyasu, S.

AU - Staffa, J. A.

AU - Dal Pan, G.

PY - 2013/9

Y1 - 2013/9

N2 - The US Food and Drug Administration emphasizes the role of regulatory science in the fulfillment of its mission to promote and protect public health and foster innovation. With respect to the evaluation of drug effects in the real world, regulatory science plays an important role in drug risk assessment and management. This article discusses opportunities and challenges with population-based drug risk assessment as well as related regulatory science knowledge gaps in the following areas: (i) population-based data sources and methods to evaluate drug safety issues; (ii) evidence-based thresholds to account for uncertainty in postmarket data; (iii) approaches to optimize the integration and interpretation of evidence from different sources; and (iv) approaches to evaluate the real-world impact of regulatory decisions. Regulators should continue the ongoing dialogue with multiple stakeholders to strengthen regulatory safety science and address these and other critical knowledge gaps.

AB - The US Food and Drug Administration emphasizes the role of regulatory science in the fulfillment of its mission to promote and protect public health and foster innovation. With respect to the evaluation of drug effects in the real world, regulatory science plays an important role in drug risk assessment and management. This article discusses opportunities and challenges with population-based drug risk assessment as well as related regulatory science knowledge gaps in the following areas: (i) population-based data sources and methods to evaluate drug safety issues; (ii) evidence-based thresholds to account for uncertainty in postmarket data; (iii) approaches to optimize the integration and interpretation of evidence from different sources; and (iv) approaches to evaluate the real-world impact of regulatory decisions. Regulators should continue the ongoing dialogue with multiple stakeholders to strengthen regulatory safety science and address these and other critical knowledge gaps.

UR - http://www.scopus.com/inward/record.url?scp=84883202910&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84883202910&partnerID=8YFLogxK

U2 - 10.1038/clpt.2013.118

DO - 10.1038/clpt.2013.118

M3 - Article

C2 - 23739537

AN - SCOPUS:84883202910

VL - 94

SP - 349

EP - 358

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

SN - 0009-9236

IS - 3

ER -