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Regulatory affairs

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
Lucian Beer, Michael Mildner, Hendrik Jan Ankersmit
No abstract text is available yet for this article.
April 2017: Annals of Translational Medicine
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
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
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
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...
March 15, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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
Daniel Friedman, Joseph I Sirven
There has been a dramatic surge in the interest of utilizing cannabis for epilepsy treatment in the US. Yet, access to cannabis for research and therapy is mired in conflicting regulatory policies and shifting public opinion. Understanding the current state of affairs in the medical cannabis debate requires an examination of the history of medical cannabis use. From ancient Chinese pharmacopeias to the current Phase III trials of pharmaceutical grade cannabidiol, this review covers the time span of cannabis use for epilepsy therapy so as to better assess the issues surrounding the modern medical opinion of cannabis use...
January 11, 2017: Epilepsy & Behavior: E&B
Lila Ramaiah, Lindsay Tomlinson, Niraj K Tripathi, Laura C Cregar, Allison Vitsky, Barbara von Beust, Valerie G Barlow, William J Reagan, Daniela Ennulat
There is limited direction in the literature or regulatory guidance on determination of adversity for clinical pathology (CP) biomarkers in preclinical safety studies. Toxicologic clinical pathologists representing the American Society for Veterinary Clinical Pathology-Regulatory Affairs Committee and Society of Toxicologic Pathology-Clinical Pathology Interest Group identified principles, overall approach, and unique considerations for assessing adversity in CP data interpretation to provide a consensus opinion...
February 2017: Toxicologic Pathology
Lisa Zubkoff, Brian Shiner, Bradley V Watts
INTRODUCTION: Guidelines recommend that substance use disorder (SUD) treatment be available in primary care-mental health integrated clinics, which offer mental and behavioral health assessment and treatment in the primary care setting. Despite this recommendation it is unclear what barriers and facilitators exist to SUD treatment being provided in that setting. This work sought to understand current SUD services in such integrated clinics, explore other services may that be appropriate, and identify barriers to such services...
November 2016: Journal of Substance Abuse Treatment
Greg Troiano, Jim Nolan, Donald Parsons, Christina Van Geen Hoven, Stephen Zale
The translation of nanomedicines from concepts to commercial products has not reached its full potential, in part because of the technical and regulatory challenges associated with chemistry, manufacturing, and controls (CMC) development of such complex products. It is critical to take a quality by design (QbD) approach to developing nanomedicines-using a risk-based approach to identifying and classifying product attributes and process parameters and ultimately developing a deep understanding of the products, processes, and platform...
2016: AAPS Journal
Margot A Cousin, Alexandra J Greenberg, Tyler H Koep, Diana Angius, Michael J Yaszemski, Robert J Spinner, Anthony J Windebank
Little quantitative data exist concerning barriers that impede translation from bench to bedside. We systematically reviewed synthetic or biosynthetic polymer nerve scaffolds for peripheral nerve repair to study a defined research area that is beyond the discovery phase and has potential for clinical application. Using electronic and manual search methods, we identified published English language articles, where scaffolds were tested in preclinical animal models. A systematic review of these 416 reports estimated all costs related to the use of animals, surgery, and evaluation methods...
December 2016: Tissue Engineering. Part B, Reviews
Héctor Bueno, Pieter de Graeff, Isabelle Richard-Lordereau, Joseph Emmerich, Keith Aa Fox, Carola P Friedman, Christophe Gaudin, Amany El-Gazayerly, Samantha Goldman, Melanie Hemmrich, Robert A Henderson, Anders Himmelmann, Alar Irs, Neville Jackson, Stefan K James, Hugo A Katus, Andrea Laslop, Ian Laws, Roxana Mehran, Seleen Ong, Krishna Prasad, Marco Roffi, Giuseppe Mc Rosano, Martin Rose, Peter R Sinnaeve, Wendy Gattis Stough, Kristian Thygesen, Frans Van de Werf, Claire Varin, Freek Wa Verheugt, Maria de Los Angeles Alonso García
Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic researchers, trialists, European and US regulators, and pharmaceutical industry researchers...
June 29, 2016: European Heart Journal. Acute Cardiovascular Care
Chieko Kurihara, Tomio Inoue
OBJECTIVES: To identify regulatory framework for approval of PET drugs in Korea. METHOD: Interview and literature survey. RESULTS: In Korea Good Manufacturing Practice (GMP) regulation specific to radiopharmaceuticals, including PET (Positron Emission Tomography) drugs, under the Pharmaceutical Affairs Act was issued in August 2014, to be enforced on July 1, 2015, and its guidance was issued in December 2014. The new facilities to be established after July 1 of 2015 have to be compatible with this new regulation and already established facilities have two years grace period until June 30 of 2017...
November 2015: Kaku Igaku. the Japanese Journal of Nuclear Medicine
Yang Zhou, Jing-Xin Li, Peng-Fei Jin, Yu-Xiao Wang, Feng-Cai Zhu
INTRODUCTION: Enterovirus A71 (EV71) is the predominant causative agent of hand, foot, and mouth disease (HFMD), which is often associated with severe cases and even deaths. EV71-associated epidemics have emerged as a serious threat to public health, particularly in the Asia-Pacific region. AREAS COVERED: We searched PubMed using the terms 'enterovirus 71', 'hand, foot, and mouth disease', and 'vaccine', with no date or language restrictions for all publications before April 27, 2016...
July 2016: Expert Review of Vaccines
Shyam B Verma, Resham Vasani
Genital dermatophytosis has been considered rare by most Western authorities. However, to the contrary, Indian reports have shown a higher prevalence of genital dermatophytosis due to warm and humid climate, overcrowding and lack of hygiene. A review is presented for 24 cases of male genital dermatophytosis occurring in patients suffering from tinea cruris in India who have been randomly applying various broad-spectrum steroid antifungal and antibacterial creams containing one or more antifungal and antibiotic in addition to potent corticosteroids, mainly clobetasol propionate...
October 2016: Mycoses
H O Lyon
In the 17(th) issue of News from the Biological Stain Commission (BSC) under the heading of Regulatory affairs, the Biological Stain Commission's International Affairs Committee presents information from the 20(th) meeting of ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems held on October 15 - 17, 2014 in Toronto, Canada, and from the 29(th) meeting of CEN/TC 140 In vitro diagnostic medical devices held on February 3, 2015 in Berlin, Germany.
2016: Biotechnic & Histochemistry: Official Publication of the Biological Stain Commission
(no author information available yet)
The Department of Veterans Affairs (VA) adopts as final an interim final rule that amends its medical regulation that governs Vet Center services. The National Defense Authorization Act for Fiscal Year 2013 (the 2013 Act) requires Vet Centers to provide readjustment counseling services to broader groups of veterans, members of the Armed Forces, including a member of a reserve component of the Armed Forces, and family members of such veterans and members. This final rule adopts as final the regulatory criteria to conform to the 2013 Act, to include new and revised definitions...
March 2, 2016: Federal Register
J Mattner, F Schmidt, B Siegmund
Faecal microbiota transplantation has gained increasing attention over the last decade as various phenotypes could be transferred from a donor to a recipient in different animal models. Clinically, however, the sole indication with evidence from a randomized placebo controlled trial is refractory Clostridium difficile infection. Despite revealing successful clinical outcomes, questions concerning regulatory affairs, the identification of the best donor, the optimal mixture of the transplant as well as the preferred route of administration remain to be clarified even for this indication...
August 2016: International Journal of Medical Microbiology: IJMM
David J Taber, Mulugeta Gebregziabher, Elizabeth H Payne, Titte Srinivas, Prabhakar K Baliga, Leonard E Egede
BACKGROUND: Black kidney transplant recipients experience disproportionately high rates of graft loss. This disparity has persisted for 40 years, and improvements may be impeded based on the current public reporting of overall graft loss by US regulatory organizations for transplantation. METHODS: Longitudinal cohort study of kidney transplant recipients using a data set created by linking Veterans Affairs and US Renal Data System information, including 4918 veterans transplanted between January 2001 and December 2007, with follow-up through December 2010...
February 2017: Transplantation
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