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The US Food and Drug Administration-European Medicines Agency Collaboration in Pharmacovigilance: Common Objectives and Common Challenges

Gerald J. Dal Pan, Peter R. Arlett
2014 Drug Safety  
On 19 February 2014, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) announced the formation of a cluster on pharmacovigilance topics.  ...  The creation of the cluster formalizes this longstanding and productive relationship and facilitates more systematic exchange of information and expertise.  ...  These bodies promote the global importance of post-marketing drug safety and provide a global platform for adverse event data collection (WHO), propose broad frameworks for postapproval safety activities  ... 
doi:10.1007/s40264-014-0259-3 pmid:25539878 fatcat:hcca7bzjlncavoycecwodf5234

Post-market surveillance to detect adverse events associated with Melody® valve implantation

Kevin D. Hill, Bryan H. Goldstein, Michael J. Angtuaco, Patricia Y. Chu, Gregory A. Fleming
2016 Cardiology in the Young  
Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials.  ...  Conclusion Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with "on-label" Melody® valve implantation.  ...  Acknowledgments Funding sources: This work was supported in part by a grant from The National Center for Advancing Translational Sciences of the National Institutes of Health (KL2TR001115-02).  ... 
doi:10.1017/s1047951116002092 pmid:27829472 pmcid:PMC5425318 fatcat:bvpn77n2f5eatcyvovthzjhjzy

Drug effectiveness reporting and monitoring systems: discussion and prototype development

Amar Gupta, Igor Crk, Surendra Sarnikar, Bipin Karunakaran
2009 International Journal of Technology Management  
Current techniques for post-approval monitoring are not adequate for timely discovery of as-of-yet unknown adverse events.  ...  We have found a need for similar monitoring for drugs that have just entered the market and whose potential adverse events are not yet known.  ...  Woosley and others of The Critical Path Institute for their sponsorship of this project involving research and development of the concept development prototype system. References  ... 
doi:10.1504/ijtm.2009.024121 fatcat:thds5n7nv5g6fpaofwvlhkqefy

The Drug Effectiveness Reporting and Monitoring System: Discussion and Prototype Development

Amar Gupta, Igor Crk, Surendra Sarnikar, Bipin Karunakaran
2006 Social Science Research Network  
Current techniques for post-approval monitoring are not adequate for timely discovery of as-of-yet unknown adverse events.  ...  We have found a need for similar monitoring for drugs that have just entered the market and whose potential adverse events are not yet known.  ...  Woosley and others of The Critical Path Institute for their sponsorship of this project involving research and development of the concept development prototype system. References  ... 
doi:10.2139/ssrn.940447 fatcat:7pf7qzasfvecvcklzzus4priqu

Duloxetine and Pregnancy Outcomes: Safety Surveillance Findings

Sharon L Hoog, Yingkai Cheng, John Elpers, Sherie A Dowsett
2013 International Journal of Medical Sciences  
Post-marketing surveillance is an important tool for the assessment of drug safety in pregnancy in a naturalistic setting.  ...  Both databases provided spontaneous reporting data from the time of first duloxetine marketing authorization in 2004; in addition, the LSS Database includes serious adverse event and pregnancy data from  ...  AERS Database The AERs database was designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products.  ... 
doi:10.7150/ijms.5213 pmid:23471302 pmcid:PMC3590601 fatcat:p3q2zx53h5b7fjr6gg2jlpimz4

PathFX provides mechanistic insights into drug efficacy and safety for regulatory review and therapeutic development

Jennifer L. Wilson, Rebecca Racz, Tianyun Liu, Oluseyi Adeniyi, Jielin Sun, Anuradha Ramamoorthy, Michael Pacanowski, Russ Altman, Avner Schlessinger
2018 PLoS Computational Biology  
We then used PathFX to strengthen signals for drug-adverse event pairs occurring in the FDA Adverse Event Reporting System (FAERS) and also identified opportunities for drug repurposing for new diseases  ...  We benchmarked PathFX by identifying drugs' marketed disease indications and reported a sensitivity of 41%, a 2.7-fold improvement over similar approaches.  ...  Acknowledgments Some of the computing for this project was performed on the Sherlock cluster.  ... 
doi:10.1371/journal.pcbi.1006614 pmid:30532240 pmcid:PMC6285459 fatcat:tksagcvx7ff3rignvw7mlatoda

Effect of pharmacovigilance training programme on quantitative and qualitative adverse drug reaction reporting

Sangita D. Jogdand, Mugdha R. Padhye, Shailesh Nagpure, Raju K. Shinde
2017 International Journal of Basic & Clinical Pharmacology  
Adverse Drug Reactions(ADRs) are required to monitored in post marketing phase for unstudied ADR or beneficial effect which were not evident in controlled study design, but ADRs are usually under reported  ...  There is increasing numbers of adverse drug reaction monitoring centers in India affiliated to governing council but are in primitive phase.  ...  INTRODUCTION Vast numbers of the drugs are available in markets which are widely prescribed by physician that leads to increased number of adverse drug reactions (ADR).  ... 
doi:10.18203/2319-2003.ijbcp20172225 fatcat:ulb6vdxz7jeeliohw5japxwlze

Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data

Handong Ma, Chunhua Weng
2016 Journal of Biomedical Informatics  
Pre-and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns.  ...  In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s).  ...  If the post-marketing trials find too many adverse events, the Food and Drug Administration will restrict the use of the drug or even mandate that it be withdrawn from the market.  ... 
doi:10.1016/j.jbi.2016.01.015 pmid:26851401 pmcid:PMC4837034 fatcat:bw5isufaxzff3lkjn4pxxrun5a

Worldwide post-marketing safety surveillance experience with tofacitinib in ulcerative colitis

David T Rubin, Irene Modesto, Séverine Vermeire, Silvio Danese, Siew C Ng, Kenneth K Kwok, Nana Koram, Thomas V Jones
2021 Alimentary Pharmacology and Therapeutics  
Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Post-marketing surveillance (PMS) is an important part of monitoring adverse events (AEs).  ...  During the 27-month reporting period, worldwide post-marketing exposure to tofacitinib was 8916 PY.  ...  All authors approved the final draft of the manuscript for submission, including the authorship list.  ... 
doi:10.1111/apt.16619 pmid:34626429 pmcid:PMC9293472 fatcat:fn265ymptbg63hcplfutdonadm

Data mining methodologies for pharmacovigilance

Mei Liu, Michael E. Matheny, Yong Hu, Hua Xu
2012 SIGKDD Explorations  
Adverse drug events have been estimated to cause over 700,000 emergency department visits each year in the United States.  ...  In the pre-marketing stages of a drug, PhV primarily focuses on predicting potential ADRs using preclinical characteristics of the compounds (e.g., drug targets, chemical structure) or screening data (  ...  [14] have shown that drugs with similar in vitro protein binding profiles tend to exhibit similar side-effects through hierarchical clustering of biological activity spectra and adverse event data of  ... 
doi:10.1145/2408736.2408742 fatcat:kkrx4ixd6fhf5lwnjqme3lynqi

A New Era of Pharmacovigilance: Future Challenges and Opportunities

Gianluca Trifirò, Salvatore Crisafulli
2022 Frontiers in Drug Safety and Regulation  
Accelerated approvals of drugs and vaccines to tackle the COVID-19 pandemic emphasized also the need to expeditely generate safety data in post-marketing setting by identifying and preventing serious risks  ...  Therefore, the post-marketing assessment of medicines plays a key role for better defining drugs' safety profile in real-world setting and filling the evidence gap of pre-marketing studies.  ...  Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.  ... 
doi:10.3389/fdsfr.2022.866898 fatcat:xekv3qcj75bmhkwecr2qa6224m

Stimulated Reporting: The Impact of US Food and Drug Administration-Issued Alerts on the Adverse Event Reporting System (FAERS)

Keith B. Hoffman, Andrea R. Demakas, Mo Dimbil, Nicholas P. Tatonetti, Colin B. Erdman
2014 Drug Safety  
The US Food and Drug Administration (FDA) uses the Adverse Event Reporting System (FAERS) to support post-marketing safety surveillance programs.  ...  Sometimes cited as a limitation of FAERS, however, is the assumption that "stimulated reporting" of adverse events (AEs) occurs in response to warnings, alerts, and label changes that are issued by the  ...  The FDA's Adverse Event Reporting System (FAERS) [9] is a centralized computerized information database that is broadly used by the agency, and other pharmacovigilance experts, for post-marketing drug  ... 
doi:10.1007/s40264-014-0225-0 pmid:25255848 pmcid:PMC4206770 fatcat:kwfumarbcjhx5lbyvhz3pcxmxq

Informatics confronts drug–drug interactions

Bethany Percha, Russ B. Altman
2013 TIPS - Trends in Pharmacological Sciences  
Many jurisdictions have their own adverse event tracking systems, but so far there is no systematic structure for cooperation. 98 Some of the most serious post-approval adverse events are the result of  ...  inherent to the drug itself, what is emerging as a more serious issue is possible "drug-drug 1 This article specifically considers post-market adverse events caused by drugs because the regulation system  ...  against the encroachment or aggrandizement of one branch at the expense of the  ... 
doi:10.1016/ pmid:23414686 pmcid:PMC3808975 fatcat:wf3h32hubjhl7oh4udke47dfly

Pharmacovigilance in Israel – tools, processes, and actions

Eyal Schwartzberg, Matitiahu Berkovitch, Dorit Dil Nahlieli, Joseph Nathan, Einat Gorelik
2017 Israel Journal of Health Policy Research  
Due to the limited safety data available at the time that a new medication is first marketed, it is essential to continue the collection and monitoring of safety data about adverse drug reactions (ADRs  ...  In 2012, the Israeli Ministry of Health (MOH) established a Pharmacovigilance and Drug Information Department.  ...  Availability of data and materials Data sharing is not applicable to this article due to confidentiality limitations. For further clarifications please contact author.  ... 
doi:10.1186/s13584-017-0154-3 pmid:28760141 pmcid:PMC5537943 fatcat:oej6q53lavfixpgxewa77xuaiu

Diplopia on vorapaxar: An unexpected side effect emerging only at second glance

L. Gross, D. Sibbing
2016 Thrombosis and Haemostasis  
Importantly, true rare adverse events are generally more likely to be identified for recently approved drugs rather than during premarketing trials.  ...  Therefore, rigorous post-marketing surveillance is of utmost importance for safe adoption of novel therapeutic agents.  ... 
doi:10.1160/th16-02-0124 pmid:26887901 fatcat:jnmqhxu2bvcclp6rs5vupox7rq
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