The Pharmaceutical Regulatory Process

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The Pharmaceutical Regulatory Process

Author : Ira R. Berry
Publisher : Drugs and the Pharmaceutical Sciences
ISBN 13 : 9781138381285
Total Pages : 650 pages
Book Rating : 4.3/5 (812 download)

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Book Synopsis The Pharmaceutical Regulatory Process by : Ira R. Berry

Download or read book The Pharmaceutical Regulatory Process written by Ira R. Berry and published by Drugs and the Pharmaceutical Sciences. This book was released on 2019-06-07 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

The Pharmaceutical Regulatory Process, Second Edition

Author : Ira R. Berry
Publisher : CRC Press
ISBN 13 : 9781420070422
Total Pages : 0 pages
Book Rating : 4.0/5 (74 download)

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Book Synopsis The Pharmaceutical Regulatory Process, Second Edition by : Ira R. Berry

Download or read book The Pharmaceutical Regulatory Process, Second Edition written by Ira R. Berry and published by CRC Press. This book was released on 2008-12-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

The Pharmaceutical Regulatory Process

Author : Ira R. Berry
Publisher : CRC Press
ISBN 13 : 9781135533564
Total Pages : 736 pages
Book Rating : 4.5/5 (335 download)

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Book Synopsis The Pharmaceutical Regulatory Process by : Ira R. Berry

Download or read book The Pharmaceutical Regulatory Process written by Ira R. Berry and published by CRC Press. This book was released on 2004-11-15 with total page 736 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.

Regulatory Affairs in the Pharmaceutical Industry

Author : Javed Ali
Publisher : Academic Press
ISBN 13 : 0128222239
Total Pages : 287 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali

Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

The Use of Drugs in Food Animals

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309175771
Total Pages : 276 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Use of Drugs in Food Animals by : National Research Council

Download or read book The Use of Drugs in Food Animals written by National Research Council and published by National Academies Press. This book was released on 1999-01-12 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.

Pharmaceutical Regulatory Environment

Author : Reem K. Al-Essa
Publisher : Springer
ISBN 13 : 3319175904
Total Pages : 246 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Pharmaceutical Regulatory Environment by : Reem K. Al-Essa

Download or read book Pharmaceutical Regulatory Environment written by Reem K. Al-Essa and published by Springer. This book was released on 2015-05-06 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

The Changing Economics of Medical Technology

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030904491X
Total Pages : 225 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Pharmaceutical Regulatory Affairs

Author : C. F. Harrison
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781537090740
Total Pages : 66 pages
Book Rating : 4.0/5 (97 download)

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Book Synopsis Pharmaceutical Regulatory Affairs by : C. F. Harrison

Download or read book Pharmaceutical Regulatory Affairs written by C. F. Harrison and published by Createspace Independent Publishing Platform. This book was released on 2016-08-19 with total page 66 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory affairs. If you're finishing your academic career and are looking for a job in biotech or pharmaceuticals, you will have seen a thousand advertisements for regulatory affairs managers. But...what exactly is regulatory affairs? What would I be doing? What sort of skills do I need? What do I need to know before I start? This book answers all these questions and more, providing an introduction to the complex world of regulatory affairs. We cover typical tasks; required skills; the ins and outs of the submission process; vital knowledge you'll need to have; and much more. Lost in a sea of acronyms? We've got you covered. Not really sure how regulatory fits into pharmaceutical development? We explain the process. No idea why your new boss keeps going on about module 3.2.P.7? No problem. Whether you're looking for a job, preparing for an interview, or have just started in the field, this book will give you the foundational knowledge you need to succeed.

Pharmaceutical Product Development

Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 438 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Pharmaceutical Product Development by : Vandana B. Patravale

Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive

FDA Regulatory Affairs

Author : David Mantus
Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)

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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.

Regulating Medicines in a Globalized World

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309498635
Total Pages : 169 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine

Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine

Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Rare Diseases and Orphan Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Guidebook for Drug Regulatory Submissions

Author : Sandy Weinberg
Publisher : John Wiley & Sons
ISBN 13 : 0470456175
Total Pages : 392 pages
Book Rating : 4.4/5 (74 download)

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Book Synopsis Guidebook for Drug Regulatory Submissions by : Sandy Weinberg

Download or read book Guidebook for Drug Regulatory Submissions written by Sandy Weinberg and published by John Wiley & Sons. This book was released on 2009-02-23 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.

FDA Regulatory Affairs

Author : Douglas J. Pisano
Publisher : CRC Press
ISBN 13 : 1040061974
Total Pages : 466 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano

Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Fundamentals of Biologicals Regulation

Author : Rebecca Sheets
Publisher : Academic Press
ISBN 13 : 0128094435
Total Pages : 450 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Fundamentals of Biologicals Regulation by : Rebecca Sheets

Download or read book Fundamentals of Biologicals Regulation written by Rebecca Sheets and published by Academic Press. This book was released on 2017-12-13 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products