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The future of population-based postmarket drug risk assessment: a regulator's perspective.
Clin Pharmacol Ther. 2013 Sep; 94(3):349-58.CP

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.

Authors+Show Affiliations

Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. tarek_hammad@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

23739537

Citation

Hammad, T A., et al. "The Future of Population-based Postmarket Drug Risk Assessment: a Regulator's Perspective." Clinical Pharmacology and Therapeutics, vol. 94, no. 3, 2013, pp. 349-58.
Hammad TA, Neyarapally GA, Iyasu S, et al. The future of population-based postmarket drug risk assessment: a regulator's perspective. Clin Pharmacol Ther. 2013;94(3):349-58.
Hammad, T. A., Neyarapally, G. A., Iyasu, S., Staffa, J. A., & Dal Pan, G. (2013). The future of population-based postmarket drug risk assessment: a regulator's perspective. Clinical Pharmacology and Therapeutics, 94(3), 349-58. https://doi.org/10.1038/clpt.2013.118
Hammad TA, et al. The Future of Population-based Postmarket Drug Risk Assessment: a Regulator's Perspective. Clin Pharmacol Ther. 2013;94(3):349-58. PubMed PMID: 23739537.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The future of population-based postmarket drug risk assessment: a regulator's perspective. AU - Hammad,T A, AU - Neyarapally,G A, AU - Iyasu,S, AU - Staffa,J A, AU - Dal Pan,G, Y1 - 2013/06/05/ PY - 2013/05/14/received PY - 2013/05/29/accepted PY - 2013/6/7/entrez PY - 2013/6/7/pubmed PY - 2013/12/18/medline SP - 349 EP - 58 JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. VL - 94 IS - 3 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. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/23739537/The_future_of_population_based_postmarket_drug_risk_assessment:_a_regulator's_perspective_ L2 - https://doi.org/10.1038/clpt.2013.118 DB - PRIME DP - Unbound Medicine ER -