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An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
  • Author : Eunjoo Pacifici
  • Publsiher : Academic Press
  • Release : 13 June 2018
  • ISBN : 0128111569
  • Pages : 280 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKAn Overview of FDA Regulated Products

Summary:
Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations


An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
  • Author : Eunjoo Pacifici,Susan Bain
  • Publisher : Academic Press
  • Release : 13 June 2018
GET THIS BOOKAn Overview of FDA Regulated Products

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key


FDA Regulatory Affairs

FDA Regulatory Affairs
  • Author : David Mantus,Douglas J. Pisano
  • Publisher : CRC Press
  • Release : 28 February 2014
GET THIS BOOKFDA Regulatory Affairs

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


Statistical Process Control for the FDA-Regulated Industry

Statistical Process Control for the FDA-Regulated Industry
  • Author : Manuel E. Pena-Rodriguez
  • Publisher : Quality Press
  • Release : 11 April 2013
GET THIS BOOKStatistical Process Control for the FDA-Regulated Industry

The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated




Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
  • Author : Rebecca Sheets
  • Publisher : Academic Press
  • Release : 13 December 2017
GET THIS BOOKFundamentals of Biologicals Regulation

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



Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology
  • Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
  • Publisher : National Academies Press
  • Release : 28 July 2017
GET THIS BOOKPreparing for Future Products of Biotechnology

Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future


FDA in the Twenty-First Century

FDA in the Twenty-First Century
  • Author : Holly Fernandez Lynch,I. Glenn Cohen
  • Publisher : Columbia University Press
  • Release : 08 September 2015
GET THIS BOOKFDA in the Twenty-First Century

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new