Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition PDF Download
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Author: Gloria Hall
Publisher:
ISBN: 9781947493513
Category : Biologicals
Languages : en
Pages :
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493513
Category : Biologicals
Languages : en
Pages :
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Book Description
Author: David Mantus
Publisher: CRC Press
ISBN: 1841849197
Category : Medical
Languages : en
Pages : 402
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Book Description
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: Regulatory Affairs Professionals Society
Publisher:
ISBN: 9781947493865
Category :
Languages : en
Pages : 0
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493698
Category :
Languages : en
Pages :
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493216
Category :
Languages : en
Pages :
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Book Description
Author: Pamela A. Jones
Publisher:
ISBN: 9781947493315
Category : Biologicals
Languages : en
Pages :
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493124
Category :
Languages : en
Pages :
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Book Description
Author: Syed Rizwanuddin Ahmad
Publisher:
ISBN: 9781947493018
Category :
Languages : en
Pages :
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Book Description
Laws and regulations governing pharmaceutical and biologics products manufacture and marketing in the US.
Author: Zeeshaan Arshad
Publisher:
ISBN: 9780997769739
Category : Biologicals
Languages : en
Pages : 252
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Book Description
Author: Douglas J. Pisano
Publisher: CRC Press
ISBN: 1040061974
Category : Medical
Languages : en
Pages : 466
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Book Description
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
