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A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions VIEWPOINT ONLINE FIRST A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions Opportunities Provided by a New IOM Report reports. In the United States, improvements in the Adverse Bruce M. Psaty, MD, PhD Event Reporting System (AERS), a passive surveillance sys- Eric M. Meslin, PhD tem that uses spontaneous reports of drug safety, pro- Alasdair Breckenridge, MD, FRCP duced 153 early but uncertain warnings in the FDA sum- mary reports between 2008 and 2010; 74 of the 153 early N THE POSTMARKET SETTING, THE REGULATION OF MEDICINES warnings (48%) led to changes to product labels, most com- requires an assessment of the balance between their ben- monly to sections on warnings and precautions. For ex- efits and risks and, as new information becomes available, ample, the warnings section for adalimumab was updated Imay require regulatory actions that range from changes in to include optic neuritis in December 2011. the product label to withdrawal of a drug from the market. A In some instances, postmarket safety issues may not be- series of unforeseen consequences of drug administration to come apparent until several years after approval. In 1999, for vulnerablepatientshasshapedthemodernhistoryoftheregu- instance, marketing authorization was granted both in http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

JAMA , Volume 307 (23) – Jun 20, 2012

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Publisher
American Medical Association
Copyright
Copyright 2012 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.5545
pmid
22563032
Publisher site
See Article on Publisher Site

Abstract

VIEWPOINT ONLINE FIRST A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions Opportunities Provided by a New IOM Report reports. In the United States, improvements in the Adverse Bruce M. Psaty, MD, PhD Event Reporting System (AERS), a passive surveillance sys- Eric M. Meslin, PhD tem that uses spontaneous reports of drug safety, pro- Alasdair Breckenridge, MD, FRCP duced 153 early but uncertain warnings in the FDA sum- mary reports between 2008 and 2010; 74 of the 153 early N THE POSTMARKET SETTING, THE REGULATION OF MEDICINES warnings (48%) led to changes to product labels, most com- requires an assessment of the balance between their ben- monly to sections on warnings and precautions. For ex- efits and risks and, as new information becomes available, ample, the warnings section for adalimumab was updated Imay require regulatory actions that range from changes in to include optic neuritis in December 2011. the product label to withdrawal of a drug from the market. A In some instances, postmarket safety issues may not be- series of unforeseen consequences of drug administration to come apparent until several years after approval. In 1999, for vulnerablepatientshasshapedthemodernhistoryoftheregu- instance, marketing authorization was granted both in

Journal

JAMAAmerican Medical Association

Published: Jun 20, 2012

References