Download or read book Targeted Regulatory Writing Techniques Clinical Documents for Drugs and Biologics written by Linda Fossati Wood and published by Springer Science & Business Media. This book was released on 2009-01-05 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Download or read book Regulatory Writing an Overview Second Edition written by Gloria Hall and published by . This book was released on 2020-12-04 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book From Black Codes to Recodification written by Miriam F. Williams and published by Routledge. This book was released on 2017-09-04 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: First Published in 2017. This book examines Texas regulations dating as far back as the Texas Black Codes of 1866 to contemporary Texas Child Care Licensing regulations. It presents case studies that test contemporary African American perceptions of various styles of regulatory writing.
Download or read book Document Drafting Handbook written by Gladys Q. Ramey and published by . This book was released on 1991 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Download or read book Regulatory Breakdown written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2012-08-16 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.
Download or read book Guidebook for Drug Regulatory Submissions written by Sandy Weinberg and published by John Wiley & Sons. This book was released on 2009-03-11 with total page 390 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.
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.
Download or read book Writing and Motivation written by Suzanne Hidi and published by BRILL. This book was released on 2006-11-01 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this volume is to bring together contributions from international research on writing and motivation. It not only addresses the basic question of how motivation to write can be fostered, but also provides analyses of conceptual and theoretical issues at the intersection of the topics of motivation and writing. What emerges from the various chapters is that the motivational aspects of writing represent a rich, productive and partially still unexplored research field. This volume is a step in the direction of a more systematic analysis of the problems as well as an effort to present and compare various models, perspectives and methods of motivation and writing. It addresses the implications of writing instruction based on the 2 main approaches to writing research: cognitive and socio-cultural. It provides systematic analysis of the various models, perspectives, and methods of motivation and writing. It brings together the international research available in this burgeoning field.
Download or read book Regulatory Writing written by Danny Benau and published by . This book was released on 2017-04 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book New Drug Development written by Mark P. Mathieu and published by Omec. This book was released on 1987 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Practical Guide to FDA s Food and Drug Law and Regulation Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Download or read book Preventing Regulatory Capture written by Daniel Carpenter and published by Cambridge University Press. This book was released on 2014 with total page 531 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.
Download or read book Reviving Rationality written by Michael A. Livermore and published by Oxford University Press, USA. This book was released on 2020-12-07 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: Politics and regulation -- A threatening synthesis -- Staying in bounds -- A retreat from reason -- The illusion of costs without benefits -- Erasing public health science -- Resurrecting discredited models -- Ignoring indirect benefits -- Trivializing climate change -- Manipulating transfers -- Future directions -- Improving the guardrails.
Download or read book The English Grammar Workbook for Adults written by Michael DiGiacomo and published by Rockridge Press. This book was released on 2020-06-02 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The engaging, self-guided way to learn how to write better in English Mastering English grammar can be a real challenge. But, with a little practice and patience, you can discover how to communicate better through self-study in your spare time. The English Grammar Workbook for Adults is here to help improve your writing fluency so you can gain confidence while crafting emails, cover letters, conducting daily business, and personal correspondence. No matter your current skill level, this English grammar workbook has everything you need to learn essential elements, including nouns, verbs, adjectives, adverbs, tenses, and beyond. Then, you'll apply what you've learned to everyday situations you could encounter at school, at work, social situations, creative writing, online, and more. The English Grammar Workbook for Adults features: Fun & functional--This clear, concise book is essential for ESL/EFL and other grammar students who want to work on writing English. Situational success--Get expert tips on how grammar applies to real-world scenarios. Easy to use--Find quick answers to your English grammar questions using text boxes and the expanded index in the back of the book. Learning how to communicate more clearly is a snap with The English Grammar Workbook for Adults.
Download or read book Regulatory Rights written by Larry Yackle and published by University of Chicago Press. This book was released on 2008-09-15 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: We often hear—with particular frequency during recent Supreme Court nomination hearings—that justices should not create constitutional rights, but should instead enforce the rights that the Constitution enshrines. In Regulatory Rights, Larry Yackle sets out to convince readers that such arguments fundamentally misconceive both the work that justices do and the character of the American Constitution in whose name they do it. It matters who sits on the Supreme Court, he argues, precisely because justices do create individual constitutional rights. Traversing a wide range of Supreme Court decisions that established crucial precedents about racial discrimination, the death penalty, and sexual freedom, Yackle contends that the rights we enjoy are neither more nor less than what the justices choose to make of them. Regulatory Rights is a bracing read that will be heatedly debated by all those interested in constitutional law and the judiciary.
Download or read book Achieving Regulatory Excellence written by Cary Coglianese and published by Brookings Institution Press. This book was released on 2016-12-20 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger.
