Fda Regulatory Affairs

FDA Regulatory Affairs PDF
Author: David Mantus
Publisher: CRC Press
ISBN: 1841849197
Size: 44.29 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 400
View: 2615

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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.

Fda Regulatory Affairs

FDA Regulatory Affairs PDF
Author: Douglas J. Pisano
Publisher: Informa Health Care
ISBN: 1420073540
Size: 41.74 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 464
View: 2976

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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 a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track

Medical Product Regulatory Affairs

Medical Product Regulatory Affairs PDF
Author: John J. Tobin
Publisher: John Wiley & Sons
ISBN: 3527644717
Size: 74.44 MB
Format: PDF, Mobi
Category : Science
Languages : en
Pages : 297
View: 3837

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Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Us Fda Compliance Policy Guide Cpg

US FDA Compliance Policy Guide  CPG  PDF
Author: United States. Food and Drug Administration. Office of Regulatory Affairs
Publisher:
ISBN:
Size: 20.69 MB
Format: PDF
Category : Medical instruments and apparatus
Languages : en
Pages :
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Pharmaceutical Competitive Intelligence For The Regulatory Affairs Professional

Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional PDF
Author: Raymond A. Huml
Publisher: Springer Science & Business Media
ISBN: 1461436826
Size: 36.39 MB
Format: PDF, ePub
Category : Medical
Languages : en
Pages : 82
View: 3466

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This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product’s lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions. ​

Consumer Sourcebook

Consumer Sourcebook PDF
Author: Matthew Miskelly
Publisher: Gale Cengage
ISBN: 9780787680930
Size: 29.24 MB
Format: PDF
Category : Business & Economics
Languages : en
Pages : 1545
View: 6053

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P IConsumer Sourcebook /I provides a comprehensive digest of accessible resources and advisory information for the American consumer. This new edition identifies and describes some 23,000 programs and services available to the general public at little or no cost. These services are provided by federal, state, county, and local governments and their agencies as well as by organizations and associations. PConsumer affairs and customer services departments for corporations are also listed as well as related publications, multimedia products, general tips and recommendations for consumers. The master index is arranged alphabetically by name and by subject term.