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Regulatory affairs

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...
January 1, 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...
November 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 19, 2016: Transplantation
Zhihong Lai, Anna La Noce
The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as would be anticipated for a biosimilar product, and not receive regulatory approval based on current guidance. In order to demonstrate similarity of a biosimilar product versus the originator (ie, the branded product), based on regulatory guidance, a stepwise approach is usually taken, starting with a comprehensive structural and functional characterisation of the new biological moiety...
2016: RMD Open
Ichiro Sakuma
For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted...
August 2015: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
Kim H Esbensen, Andrés D Román-Ospino, Adriluz Sanchez, Rodolfo J Romañach
In spite of intense efforts in the last 20 years, the current state of affairs regarding evaluation of adequacy of pharmaceutical mixing is at an impressive standstill, characterized by two draft guidances, one withdrawn, and the other never approved. We here analyze the regulatory, scientific and technological situation and suggest a radical, but logical approach calling for a paradigm shift regarding sampling of pharmaceutical blends. In synergy with QbD/PAT efforts, blend uniformity testing should only be performed with properly designed sampling that can guarantee representativity-in contrast to the current deficient thief sampling...
February 29, 2016: International Journal of Pharmaceutics
N F Fayzrakhmanov
BACKGROUND: The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. OBJECTIVE: To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. METHODS: The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analysis of regulatory legal acts in the sphere of criminal law and turnover of medicinal products; review of scientific and practical publications...
2015: International Journal of Risk & Safety in Medicine
(no author information available yet)
The Department of Veterans Affairs (VA) revises its medical regulations that implement section 101 of the Veterans Access, Choice, and Accountability Act of 2014 (hereafter referred to as "the Choice Act"), which requires VA to establish a program to furnish hospital care and medical services through eligible non-VA health care providers to eligible veterans who either cannot be seen within the wait-time goals of the Veterans Health Administration (VHA) or who qualify based on their place of residence (hereafter referred to as the "Veterans Choice Program" or the "Program")...
December 1, 2015: Federal Register
Debra L Murphy
No abstract text is available yet for this article.
July 2015: Radiology Management
Robert M Califf, Jeremy Sugarman
The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges...
October 2015: Clinical Trials: Journal of the Society for Clinical Trials
Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, Won Shin
The Ministry of Food and Drug Safety regulates gene therapy and cell therapy products as biological products under the authority of the Pharmaceutical Affairs Act. As with other medicinal products, gene therapy and cell therapy products are subject to approval for use in clinical trials and for a subsequent marketing authorization and to post-market surveillance. Research and development of gene therapy and cell therapy products have been progressing rapidly in Korea with extensive investment, offering great potential for the treatment of various serious diseases...
2015: Advances in Experimental Medicine and Biology
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