keyword
MENU ▼
Read by QxMD icon Read
search

Regulatory affairs

keyword
https://www.readbyqxmd.com/read/29118898/power-to-the-people-data-citizens-in-the-age-of-precision-medicine
#1
Barbara J Evans
Twentieth-century bioethics celebrated individual autonomy but framed autonomy largely in terms of an individual's power to make decisions and act alone. The most pressing challenges of big data science in the twenty-first century can only be resolved through collective action and common purpose. This Article surveys some of these challenges and asks how common purpose can ever emerge on the present bioethical and regulatory landscape. The solution may lie in embracing a broader concept of autonomy that empowers individuals to protect their interests by exercising meaningful rights of data citizenship...
2017: Vanderbilt J Entertain Technol Law
https://www.readbyqxmd.com/read/28986035/estimating-the-full-public-health-value-of-vaccination
#2
Bradford D Gessner, David Kaslow, Jacques Louis, Kathleen Neuzil, Katherine L O'Brien, Valentina Picot, Tikki Pang, Umesh D Parashar, Mitra Saadatian-Elahi, Christopher B Nelson
There is an enhanced focus on considering the full public health value (FPHV) of vaccination when setting priorities, making regulatory decisions and establishing implementation policy for public health activities. Historically, a therapeutic paradigm has been applied to the evaluation of prophylactic vaccines and focuses on an individual benefit-risk assessment in prospective and individually-randomized phase III trials to assess safety and efficacy against etiologically-confirmed clinical outcomes. By contrast, a public health paradigm considers the population impact and encompasses measures of community benefits against a range of outcomes...
October 3, 2017: Vaccine
https://www.readbyqxmd.com/read/28966822/neuromind-past-present-and-future
#3
EDITORIAL
Pieter L Kubben
This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon - (app) developer it explains how technical progress has shaped the world's "most rated and highest rated" neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics...
2017: Surgical Neurology International
https://www.readbyqxmd.com/read/28946874/design-of-a-single-arm-clinical-trial-of-regenerative-therapy-by-periurethral-injection-of-adipose-derived-regenerative-cells-for-male-stress-urinary-incontinence-in-japan-the-adresu-study-protocol
#4
Shinobu Shimizu, Tokunori Yamamoto, Shinobu Nakayama, Akihiro Hirakawa, Yachiyo Kuwatsuka, Yasuhito Funahashi, Yoshihisa Matsukawa, Keisuke Takanari, Kazuhiro Toriyama, Yuzuru Kamei, Kazutaka Narimoto, Tomonori Yamanishi, Osamu Ishizuka, Masaaki Mizuno, Momokazu Gotoh
BACKGROUND: Male stress urinary incontinence is a prevalent condition after radical prostatectomy. While the standard recommendation for the management of urine leakage is pelvic floor muscle training, its efficacy is still unsatisfactory. Therefore, we have focused on regenerative therapy, which consists of administering a periurethral injection of autologous regenerative cells from adipose tissue, separated using the Celution® system. Based on an interim data analysis of our exploratory study, we confirmed the efficacy and acceptable safety profile of this treatment...
September 25, 2017: BMC Urology
https://www.readbyqxmd.com/read/28944731/the-fda-unapproved-drugs-initiative-an-observational-study-of-the-consequences-for-drug-prices-and-shortages-in-the-united-states
#5
Ravi Gupta, Sanket S Dhruva, Erin R Fox, Joseph S Ross
BACKGROUND: Hundreds of drug products are currently marketed in the United States without approval from the FDA. The 2006 Unapproved Drugs Initiative (UDI) requires manufacturers to remove these drug products from the market or obtain FDA approval by demonstrating evidence of safety and efficacy. Once the FDA acts against an unapproved drug, fewer manufacturers remain in the market, potentially enabling drug price increases and greater susceptibility to drug shortages. There is a need for systematic study of the UDI's effect on prices and shortages of all targeted drugs...
October 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28805416/identifying-barriers-to-culture-change-a-qualitative-analysis-of-the-obstacles-to-delivering-resident-centered-care
#6
Ryann L Engle, Denise A Tyler, Katelyn E Gormley, Melissa K Afable, Kimberly Curyto, Omonyêlé L Adjognon, Victoria A Parker, Jennifer L Sullivan
A growing number of healthcare organizations have moved from traditional, institutional nursing home models to ones that emphasize culture change, or resident-centered care (RCC). In 2006, the Department of Veterans Affairs (VA) began implementing a number of changes to VA nursing homes, now called Community Living Centers (CLCs), to provide veterans with a more resident-centered and homelike environment. This study aimed to understand the barriers CLC staff face when delivering RCC. Ten CLCs were included on the basis of their performance levels on RCC and quality of care...
August 2017: Psychological Services
https://www.readbyqxmd.com/read/28772191/synthetic-genetic-circuits-in-crop-plants
#7
REVIEW
Orlando de Lange, Eric Klavins, Jennifer Nemhauser
The love affair between crop breeding and genetics began over a century ago and has continued unabated, from mass selection programs to targeted genome modifications. Synthetic genetic circuits, a recent development, are combinations of regulatory and coding DNA introduced into a crop plant to achieve a desired function. Genetic circuits could accelerate crop improvement, allowing complex traits to be rationally designed and requisite DNA parts delivered directly into a genome of interest. However, there is not yet a standardized pipeline from exploratory laboratory testing to crop trials, and bringing transgenic products to market remains a considerable barrier...
July 31, 2017: Current Opinion in Biotechnology
https://www.readbyqxmd.com/read/28718903/affairs-of-the-heart-innovation-in-cardiovascular-research-and-development
#8
EDITORIAL
P Honig, A Terzic
Cardiovascular disease represents the single largest contributor to morbidity and mortality, yet the flow of therapeutic innovation is lagging. Globally, academia, industry, and regulatory agencies must work together to address this gap, and ensure new disruptive therapeutic modalities to address growing needs of patients and society.
August 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28688085/fit-for-purpose-and-modern-validity-theory-in-clinical-outcomes-assessment
#9
Michael C Edwards, Ashley Slagle, Jonathan D Rubright, R J Wirth
PURPOSE: The US Food and Drug Administration (FDA), as part of its regulatory mission, is charged with determining whether a clinical outcome assessment (COA) is "fit for purpose" when used in clinical trials to support drug approval and product labeling. In this paper, we will provide a review (and some commentary) on the current state of affairs in COA development/evaluation/use with a focus on one aspect: How do you know you are measuring the right thing? In the psychometric literature, this concept is referred to broadly as validity and has itself evolved over many years of research and application...
July 7, 2017: Quality of Life Research
https://www.readbyqxmd.com/read/28607236/sri-lanka-s-national-assessment-on-innovation-and-intellectual-property-for-access-to-medical-products
#10
Hemantha Beneragama, Manisha Shridhar, Thushara Ranasinghe, Vajira Hw Dissanayake
In 2008, the Global strategy and plan of action on public health, innovation and intellectual property (GSPA-PHI) was launched by the World Health Organization, to stimulate fresh thinking on innovation in, and access to, medicines and to build sustainable research on diseases disproportionately affecting low- and middle-income countries. As part of the activities of the GSPA-PHI, Sri Lanka has been the first country to date to assess the national environment for medical technology and innovation. This year-long, multistakeholder, participative analysis facilitated identification of clear and implementable policy recommendations, for the government to increase its effectiveness in promoting innovation in health products through institutional development, investment and coordination among all areas relevant to public health...
September 2016: WHO South-East Asia Journal of Public Health
https://www.readbyqxmd.com/read/28606620/efficacy-and-safety-of-lumacaftor-and-ivacaftor-in-patients-aged-6-11-years-with-cystic-fibrosis-homozygous-for-f508del-cftr-a-randomised-placebo-controlled-phase-3-trial
#11
Felix Ratjen, Christopher Hug, Gautham Marigowda, Simon Tian, Xiaohong Huang, Sanja Stanojevic, Carlos E Milla, Paul D Robinson, David Waltz, Jane C Davies
BACKGROUND: Lumacaftor and ivacaftor combination treatment showed efficacy in patients aged 12 years or older with cystic fibrosis homozygous for F508del-cystic fibrosis transmembrane conductance regulator (CFTR) in placebo-controlled studies and patients aged 6-11 years with cystic fibrosis homozygous for F508del-CFTR in an open-label study. We report efficacy and safety of lumacaftor and ivacaftor in patients with cystic fibrosis aged 6-11 years homozygous for F508del-CFTR. METHODS: In this phase 3, randomised, double-blind, placebo-controlled, multicentre study, patients were enrolled at 54 hospitals and medical centres in nine countries (the USA, Australia, Belgium, Canada, Denmark, France, Germany, Sweden, and the UK)...
July 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28583045/recommendations-for-clinical-pathology-data-generation-interpretation-and-reporting-in-target-animal-safety-studies-for-veterinary-drug-development
#12
William Siska, Aradhana Gupta, Lindsay Tomlinson, Niraj Tripathi, Barbara von Beust
Clinical pathology testing is routinely performed in target animal safety studies in order to identify potential toxicity associated with administration of an investigational veterinary pharmaceutical product. Regulatory and other testing guidelines that address such studies provide recommendations for clinical pathology testing but occasionally contain outdated analytes and do not take into account interspecies physiologic differences that affect the practical selection of appropriate clinical pathology tests...
July 2017: International Journal of Toxicology
https://www.readbyqxmd.com/read/28562116/pharmacovigilance-in-russia-current-state-of-affairs-challenges-and-prospects
#13
Geliya Gildeeva, Andrey Belostotsky
This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV...
June 25, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28498728/a-family-affair-a-ral-exocyst-centered-network-links-ras-rac-rho-signaling-to-control-cell-migration
#14
Giulia Zago, Marco Biondini, Jacques Camonis, Maria Carla Parrini
Cell migration is central to many developmental, physiologic and pathological processes, including cancer progression. The Ral GTPases (RalA and RalB) which act down-stream the Ras oncogenes, are key players in the coordination between membrane trafficking and actin polymerization. A major direct effector of Ral, the exocyst complex, works in polarized exocytosis and is at the center of multiple protein-protein interactions that support cell migration by promoting protrusion formation, front-rear polarization, and extra-cellular matrix degradation...
May 12, 2017: Small GTPases
https://www.readbyqxmd.com/read/28480206/cell-secretome-based-drug-substances-in-regenerative-medicine-when-regulatory-affairs-meet-basic-science
#15
EDITORIAL
Lucian Beer, Michael Mildner, Hendrik Jan Ankersmit
No abstract text is available yet for this article.
April 2017: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28437620/american-association-of-clinical-endocrinologists-and-american-college-of-endocrinology-guidelines-for-management-of-dyslipidemia-and-prevention-of-cardiovascular-disease
#16
Paul S Jellinger, Yehuda Handelsman, Paul D Rosenblit, Zachary T Bloomgarden, Vivian A Fonseca, Alan J Garber, George Grunberger, Chris K Guerin, David S H Bell, Jeffrey I Mechanick, Rachel Pessah-Pollack, Kathleen Wyne, Donald Smith, Eliot A Brinton, Sergio Fazio, Michael Davidson
OBJECTIVE: The development of these guidelines is mandated by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPGs). METHODS: Recommendations are based on diligent reviews of the clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols...
April 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28430700/prescriber-compliance-with-liver-monitoring-guidelines-for-pazopanib-in-the-postapproval-setting-results-from-a-distributed-research-network
#17
Sumitra Shantakumar, Beth L Nordstrom, Susan A Hall, Luc Djousse, Myrthe P P van Herk-Sukel, Kathy H Fraeman, David R Gagnon, Karen Chagin, Jeanenne J Nelson
OBJECTIVES: Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. METHODS: Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network...
April 20, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28381721/regulatory-science-in-practice-pharmaceuticals-and-medical-devices-agency
#18
REVIEW
Taisuke Hojo
Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs...
2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28299610/pharmacovigilance-of-regenerative-medicine-under-the-amended-pharmaceutical-affairs-act-in-japan
#19
Yasuko Inokuma
Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs Act in 2014. Regenerative medicine was regulated in the category of 'Medical Devices' prior to the amendment and was not covered by the Relief Service, a system that provides financial aid to people who have experienced an adverse drug reaction and developed serious side effects as a result...
June 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28228288/fda-ce-mark-or-something-else-thinking-fast-and-slow
#20
EDITORIAL
Sundeep Mishra
There is a robust debate going on among the Medical Device stake-holders whether FDA is better or CE mark or something else. Currently process of obtaining an FDA approval is bogged down by ever-increasing unpredictability, inconsistency, prolonged time, and huge expense but CE mark has its own problems. Historically, the Japanese review process has tended to be the slowest among the big three but recently with the introduction of accelerated review process there has been a significant progress. While the goal of an innovator/manufacturer is to develop, manufacture and market a medical device that addresses an unmet clinical need, the requisite regulatory approval process can be very confusing...
January 2017: Indian Heart Journal
keyword
keyword
66791
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"