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Pdufa V
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Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :184 pages Book Rating :4.:/5 (319 download)
Book Synopsis PDUFA V by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book PDUFA V written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309459575 Total Pages :483 pages Book Rating :4.3/5 (94 download)
Book Synopsis Pain Management and the Opioid Epidemic by : National Academies of Sciences, Engineering, and Medicine
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :270 pages Book Rating :4.:/5 (319 download)
Book Synopsis Reauthorization of PDUFA by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book Reauthorization of PDUFA written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :96 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA User Fees by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book FDA User Fees written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health Publisher : ISBN 13 : Total Pages :224 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA User Fees 2012 by : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Download or read book FDA User Fees 2012 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2013 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions Publisher : ISBN 13 : Total Pages :88 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA User Fee Agreements by : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Download or read book FDA User Fee Agreements written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by . This book was released on 2014 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher : ISBN 13 : Total Pages :1096 pages Book Rating :4.3/5 ( download)
Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2015 by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2015 written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2014 with total page 1096 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Oversight and Government Reform. Subcommittee on Energy Policy, Health Care, and Entitlements Publisher : ISBN 13 : Total Pages :96 pages Book Rating :4.:/5 (319 download)
Book Synopsis FDA Checkup by : United States. Congress. House. Committee on Oversight and Government Reform. Subcommittee on Energy Policy, Health Care, and Entitlements
Download or read book FDA Checkup written by United States. Congress. House. Committee on Oversight and Government Reform. Subcommittee on Energy Policy, Health Care, and Entitlements and published by . This book was released on 2014 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by : Institute of Medicine
Download or read book Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by Institute of Medicine and published by National Academies Press. This book was released on 2014-12-19 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.
Download or read book Federal Register written by and published by . This book was released on 2014 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis FDA Regulatory Affairs by : David Mantus
Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher : ISBN 13 : Total Pages :514 pages Book Rating :4.3/5 ( download)
Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2018: USDA Office of the Inspector General by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2018: USDA Office of the Inspector General written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2017 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis FDA Regulatory Affairs by : David Mantus
Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.
Author :United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Publisher : ISBN 13 : Total Pages :516 pages Book Rating :4.3/5 ( download)
Book Synopsis Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2017: Statements of interested individuals and organizations by : United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Download or read book Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2017: Statements of interested individuals and organizations written by United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies and published by . This book was released on 2016 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Rare Disease Drug Development by : Raymond A. Huml
Download or read book Rare Disease Drug Development written by Raymond A. Huml and published by Springer Nature. This book was released on 2021-11-08 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a broad overview of rare disease drug development. It offers unique insights from various perspectives, including third-party capital providers, caregivers, patient advocacy groups, drug development professionals, marketing and commercial experts, and patients. A unique reference, the book begins with narratives on the many challenges faced by rare disease patient and their caregivers. Subsequent chapters underscore the critical, multidimensional role of patient advocacy groups and the novel approaches to related clinical trials, investment decisions, and the optimization of rare disease registries. The book addresses various rare disease drug development processes by disciplines such as oncology, hematology, pediatrics, and gene therapy. Chapters then address the operational aspects of drug development, including approval processes, development accelerations, and market access strategies. The book concludes with reflections on the authors' case for real-world data and evidence generation in orphan medicinal drug development. Rare Disease Drug Development is an expertly written text optimized for biopharmaceutical R&D experts, commercial experts, third-party capital providers, patient advocacy groups, patients, and caregivers.
Book Synopsis Pharmaceutical Economics and Policy by : Stuart O. Schweitzer
Download or read book Pharmaceutical Economics and Policy written by Stuart O. Schweitzer and published by Oxford University Press. This book was released on 2018-05-01 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals constitute a relatively small share of the total healthcare expenditure in most developed economies, and yet they play a critical role in the ongoing debate over how best to advance, improve, and afford healthcare. Despite this, and perhaps because of this, the industry has had, for many years, an outsized claim to fame and controversy, praise and criticisms, support and condemnation. Unfortunately, many participants in the debate do not fully understand the complexities of the industry and its role in the overall healthcare system. The analytical tools of economics provide a strong foundation for a better understanding of the dynamics of the pharmaceutical industry, its contribution to health and healthcare, its dual and often conflicting priorities of affordability and innovation, as well as the various private and public policy initiatives directed at the sector. This third edition of a uniquely comprehensive and balanced examination of the industry includes several new chapters on important topics such as the full-fledged generics sector, the arrival of biosimilars or generic biological drugs, the global consolidation of manufacturers, the evolving reimbursement landscape, and the emergence of the world's most populous nations, such as China, India, and Brazil, as both suppliers and consumers of pharmaceutical products. Other chapters have been fully rewritten or extensively updated, covering such important topics as the cost efficiency of research and development, pace of new innovations, economic evaluation and value-based pricing of drugs, and public and private interventions in the industry.
Book Synopsis Oral Mucosal Drug Delivery and Therapy by : Michael J. Rathbone
Download or read book Oral Mucosal Drug Delivery and Therapy written by Michael J. Rathbone and published by Springer. This book was released on 2015-03-13 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a comprehensive overview of the current issues facing scientists working on delivering drugs locally and systemically via the membranes that line the mouth. The book describes the anatomical and physiological challenges of this route for drug delivery and how they impact the design of oral mucosal drug delivery systems. It also provides a detailed description of current oral mucosal drug delivery technologies that overcome these challenges alongside research, development and assessment methods. In 11 authoritative chapters, the book affords an in-depth evaluation of the major issues associated with this route of administration, namely the retention of the drug/product at the site of administration and increasing drug permeability through the oral mucosa. The book provides insights into the in vitro and in vivo methods available to assess drug permeability and retention, offers solutions on how to improve the permeation of the drugs through the oral mucosa, and explores approaches to prolong drug/product retention at the site of administration. It also indicates future directions in research and product development. Oral Mucosal Drug Delivery and Therapy is a key resource for those wishing to extend their knowledge of this field.
