Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158893
Category : Medical
Languages : en
Pages : 94
Get Book Here
Book Description
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
Author: Forum on Drug Discovery Development and Translation
Publisher:
ISBN: 9780309383486
Category :
Languages : en
Pages : 94
Get Book Here
Book Description
The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309284791
Category : Medical
Languages : en
Pages : 129
Get Book Here
Book Description
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 030943887X
Category : Medical
Languages : en
Pages : 105
Get Book Here
Book Description
The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309110122
Category : Medical
Languages : en
Pages : 150
Get Book Here
Book Description
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients. Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. Emerging Safety Science: Workshop Summary summarizes the events and presentations of the workshop.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Get Book Here
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Figueiredo, Isabel Vitória
Publisher: IGI Global
ISBN: 1799844870
Category : Medical
Languages : en
Pages : 248
Get Book Here
Book Description
While the pharmaceutical industry evolves, the need for curriculum changes inherently follows suit. As healthcare systems have continuously improved through the use of big data and innovative care approaches, practicing pharmacists have also had to adjust and expand their roles. As such, it is imperative that the current and future pharmaceutical workforce is properly trained, taking into account new competencies that are needed to provide exceptional multidisciplinary patient healthcare. Pedagogies for Pharmacy Curricula presents emerging teaching practices and methods for pharmacy curricula and reviews pedagogic methodologies on the scope of pharmaceutical care in pharmacy curricula. The chapters present learning outcomes on general and specific topics, impact of undergraduate interventions on patient outcomes, and comparisons between different teaching pedagogies/models. While highlighting topic areas such as perspectives on learning and teaching, evidence-based practice education, and the relationships between academia and professionals, this book is ideal for health professionals, pharmacists, teachers, schools of pharmacy, medical school faculty, international organizations, clinicians, practitioners, researchers, academicians, and students who are interested in learning about the latest pedagogic methodologies in pharmacy curricula.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309222141
Category : Medical
Languages : en
Pages : 118
Get Book Here
Book Description
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
Get Book Here
Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: Marcia Crosse
Publisher: DIANE Publishing
ISBN: 1437988296
Category : Medical
Languages : en
Pages : 58
Get Book Here
Book Description
Production delays for the 2009 H1N1 pandemic vaccine using the current egg-based production technology heightened interest in alternative technologies that could expand the supply or accelerate the availability of influenza vaccine. Within the federal government, the Dept. of Health and Human Services (HHS) and the Dept. of Defense (DOD) support the development of technologies that can be used in producing technologies that can be used in producing influenza vaccines. HHS’s Food and Drug Admin. (FDA) reviews licensing applications for new vaccine, and the Dept. of State is the U.S. diplomatic liaison to the international entity that declares worldwide pandemics. This report examines (1) federal funding from FY 2005 through March 2011 for alternative technologies and the status of manufacturers’ efforts, (2) challenges to development and licensure identified by stakeholders, and (3) how HHS is addressing those challenges. Tables and figures. This is a print on demand report.
