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Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

Richard D Boyce, John R Horn, Oktie Hassanzadeh, Anita de Waard, Jodi Schneider, Joanne S Luciano, Majid Rastegar-Mojarad, Maria Liakata
2013 Journal of Biomedical Semantics  
The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety.  ...  Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling.  ...  The content is solely the responsibility of the authors and does not represent the official views of AHRQ. JS's work was supported by Science Foundation Ireland under Grant No.  ... 
doi:10.1186/2041-1480-4-5 pmid:23351881 pmcid:PMC3698101 fatcat:bje6mmdsnrdohhfbwbuzdqt77u

Enhancing Prescription Drug Innovation and Adoption

G. Caleb Alexander, Alec B. O'Connor, Randall S. Stafford
2011 Annals of Internal Medicine  
Food and Drug Administration approval to modifying the structure of drug reimbursement.  ...  However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a market place in which most new drugs are little  ...  Alexander is supported by the Agency for Healthcare Research and Quality (K08 HS15699; RO1 HS0189960). Dr. Stafford is supported by the National Heart, Lung and Blood Institute (K24 HL086703).  ... 
doi:10.7326/0003-4819-154-12-201106210-00012 pmid:21690598 pmcid:PMC4049188 fatcat:nvdgei46hrhfjidwzu6ff7ruee

Regulatory Aspects of Optical Methods and Exogenous Targets for Cancer Detection

Willemieke S. Tummers, Jason M. Warram, Kiranya E. Tipirneni, John Fengler, Paula Jacobs, Lalitha Shankar, Lori Henderson, Betsy Ballard, T. Joshua Pfefer, Brian W. Pogue, Jamey P. Weichert, Michael Bouvet (+7 others)
2017 Cancer Research  
Because fluorescence-enhanced surgery requires a combination of both device and drug, each may be developed in conjunction, or separately, which are important considerations in the approval process.  ...  The goal of this workshop was to discuss FDA approval requirements and the expectations for approval of these novel drugs and devices, packaged separately or in combination, within the context of optical  ...  Disclosure of Potential Conflicts of Interest J. Fengler is a vice president, Technology R&D at Novadaq Technologies Inc. J. Sorger is an employee at Intuitive Surgical. J.F.  ... 
doi:10.1158/0008-5472.can-16-3217 pmid:28428283 pmcid:PMC5567809 fatcat:ylipg7v6pnfajodyd3c2pskbiu

The best pharmaceuticals for children—what can we do?

Hao Li, Fang-Hong Shi, Shi-Ying Huang, Shun-Guo Zhang, Hui-Wen Chen
2020 Translational Pediatrics  
Dose-finding studies according to ageappropriate dosing strategies should be performed before efficacy and safety studies (15) . From neonates to adults, children are in a dynamic state of growth.  ...  Research Equity Act (PREA) (US Congress, December 3, 2003) (63 FR 66632) Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric  ... 
doi:10.21037/tp.2020.02.07 pmid:32477907 pmcid:PMC7237966 fatcat:whhkqp3aufcltnhmhwuvori5hi

Regulation and Testing of Vaccines [chapter]

Marion F. Gruber, Valerie B. Marshall
2018 Plotkin's Vaccines  
Acknowledgments I would like to acknowledge the employees in the Office of Vaccines Research and Review, Office of Biostatistics and Epidemiology, and the Office of Compliance and Biologics Quality/CBER  ...  for their assistance in the preparation of this manuscript.  ...  of safety and efficacy mandated in the Drug Amendments Act of 1962.  ... 
doi:10.1016/b978-0-323-35761-6.00079-1 fatcat:ssvbjij6jnepdbns5d74g3lc2u

Adherence to preexposure chemoprophylaxis

K. Rivet Amico
2012 Current Opinion in HIV and AIDS  
Conflicts of interest Dr Amico received no external funding relating directly to the writing of this manuscript; however, she is a consultant for the iPrEx and VOICE studies and works on the following  ...  Prep trials as part of her work at the University of Connecticut: HPTN067 ADAPT, HPTN069 NEXT PrEP, and EPIC.  ...  , and, even if on the active arm, on a product with unknown efficacy and continued evaluation of safety.  ... 
doi:10.1097/coh.0b013e3283582d4a pmid:22964887 fatcat:cqlhjtvahbb47lghs34sxkf2ja

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Merina Elahi, Noha Eshera, Nkosazana Bambata, Helen Barr, Beverly Lyn-Cook, Julie Beitz, Maria Rios, Deborah R. Taylor, Marilyn Lightfoote, Nada Hanafi, Lowri DeJager, Paddy Wiesenfeld (+3 others)
2016 Journal of Women's Health  
These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in  ...  These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice.  ...  Acknowledgments This project was supported, in part, by the appointments of Merina Elahi, Noha Eshera, and Nkosazana Bambata to the Research Participation Program at the Office of Women's Health, U.S.  ... 
doi:10.1089/jwh.2015.5671 pmid:26871618 pmcid:PMC4790210 fatcat:qoi23rm2nvc7lds2lpbmhojiiu

Applying System Engineering to Pharmaceutical Safety

Nancy Leveson, Matthieu Couturier, John Thomas, Meghan Dierks, David Wierz, Bruce Psaty, Stan Finkelstein
2012 Journal of Healthcare Engineering  
In this paper, we demonstrate how to apply a new, safety engineering static and dynamic modeling and analysis approach to healthcare systems.  ...  System engineering techniques can be used in re-engineering the system as a whole to achieve the system goals, including both enhancing the safety of current drugs while, at the same time, encouraging  ...  CONFLICT OF INTEREST: The authors have no potential conflicts of interest in terms of financial support from pharmaceutical companies nor any financial stake in the use of STAMP.  ... 
doi:10.1260/2040-2295.3.3.391 fatcat:5jkofk6o65g5fmkur7f5ntjsxu

When novelty is not enough

Michael F Murphy
2008 American health & drug benefits  
Neither orderly nor fully rational, the current healthcare environment is a mosaic of providers, products, services, and intermediaries delivering healthcare, regulatory, and other government institutions  ...  from the bench to the physician-patient-payor interface.  ...  Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Control Clin Trials. 2004 Dec;25(6):535-552. 8. Watt S.  ... 
pmid:25126215 pmcid:PMC4115311 fatcat:lwddwdn3pffl5dd3sv5fdvzbim

Regulating Nanomedicine at the Food and Drug Administration

2019 The AMA Journal of Ethic  
The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations  ...  Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action.  ...  necessary to assure safety and efficacy.  ... 
doi:10.1001/amajethics.2019.347 pmid:31012422 fatcat:wmgcucjmkndtdatzrml3xv4ihq

Advancements in the co-formulation of biologic therapeutics

Veeren M. Chauhan, Hongyu Zhang, Paul A. Dalby, Jonathan W. Aylott
2020 Journal of Controlled Release  
Biologic therapeutics are the medicines of the future and are destined to transform the approaches by which the causes and symptoms of diseases are cured and alleviated.  ...  However, for this potential to be realised, advancements in co-formulation strategies for biologic therapeutics must be established.  ...  Financial and inkind support from a consortium of industrial users is also acknowledged. This work was funded by a Nottingham Research Fellowship from the University of Nottingham (VMC).  ... 
doi:10.1016/j.jconrel.2020.08.013 pmid:32798639 pmcid:PMC7426274 fatcat:w3vwlatvnzfi7pjljs43sitx6a

Do Off-label Drug Practices Argue Against FDA Efficacy Requirements? Testing an Argument by Structured Conversations with Experts

Daniel B. Klein, Alexander T. Tabarrok
2003 Social Science Research Network  
The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug's efficacy.  ...  The survey asked whether efficacy requirements should be imposed on off-label uses, and almost all physicians said no.  ...  to conduct the survey.  ... 
doi:10.2139/ssrn.425791 fatcat:teytxz2mbzhpfkuf5g2j4s72jq

Off-Label Promotion of Prescription Medicine

Narcyz Ghinea, Wendy Lipworth, Ian Kerridge
2015 Therapeutic Innovation and Regulatory Science  
'right' to promote off-label drugs on freedom of speech grounds.  ...  At the same time, the pharmaceutical industry has accused governments of applying double standards by encouraging the use of cheaper off-label alternatives to registered treatments, and defended their  ...  on safety and efficacy; 3.  ... 
doi:10.1177/2168479015570337 pmid:30222394 fatcat:tycdfva4srgorovnjnrsj2dpeq

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices

Ryan Abbott, Ian Ayres
2014 Social Science Research Network  
The FDA 's approach empowers physicians, but overshoots the mark by allowing enduring use of drugs and devices with insubstantial support of safety and efficacy.  ...  The harm of accessing unsafe products must be balanced against the harm of restricting access to effective products.  ...  trials to demonstrate safety and efficacy in humans that must be conducted at the time of use of products approved under the Animal Efficacy Rule (21 CFR 314.610(b)(l) and 601.91(b)(l))."  ... 
doi:10.2139/ssrn.2399511 fatcat:f4h2prpfcbh2lell7emnmbza6m

Dose estimation for children

Nigel Baber, Deborah Pritchard
2003 British Journal of Clinical Pharmacology  
authorities and prescribers as to the efficacy, safety and quality of new potential medicines.  ...  (UK) to monitor safety of drugs in paediatric patients [21] .  ... 
doi:10.1046/j.1365-2125.2003.01901.x pmid:14651721 pmcid:PMC1884401 fatcat:jw7gp4di4bc37lomciqq5xooau
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