Fundamentals Of Pharmaceutical And Biologics Regulations Third Edition
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Fundamentals of Pharmaceutical and Biologics Regulations Third Edition
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2020-07-29 |
Genre | : Biologicals |
ISBN | : 1947493515 |
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Fundamentals of Pharmaceutical and Biologics Regulations
Author | : Pamela A. Jones |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2019 |
Genre | : Biologicals |
ISBN | : 1947493310 |
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FDA Regulatory Affairs
Author | : David Mantus,Douglas J. Pisano |
Publsiher | : CRC Press |
Total Pages | : 402 |
Release | : 2014-02-28 |
Genre | : Medical |
ISBN | : 9781841849195 |
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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.
Fundamentals of Pharmaceutical and Biologics Regulations Fourth Edition
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2021-07-23 |
Genre | : Electronic Book |
ISBN | : 1947493698 |
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Fundamentals of Pharmaceutical and Biologics Regulations a Global Perspective
Author | : Regulatory Affairs Professionals Society |
Publsiher | : Unknown |
Total Pages | : 0 |
Release | : 2023-05 |
Genre | : Electronic Book |
ISBN | : 1947493868 |
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Fundamentals of EU Pharmaceutical and Biologics Regulations
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2018-04-23 |
Genre | : Electronic Book |
ISBN | : 1947493124 |
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Fundamentals of US Pharmaceutical and Biologics Regulations
Author | : Syed Rizwanuddin Ahmad,Cassie Alexander,Sunny Kamlesh Dave,Joy Frestedt,Michael Hinckle,Jocelyn Jennings,Kurt Karst,Kirsten Messmer,Sarah Robinson,Alexandra Beumer Sassi,Charity-Anne Schuller,Kandarp Shah,William Sietsema,Andrew Slade,James Smith,Snehal Trivedi,Martha Wells,Jennifer Wilhelm,Linda Yang |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2017-08 |
Genre | : Electronic Book |
ISBN | : 1947493019 |
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Laws and regulations governing pharmaceutical and biologics products manufacture and marketing in the US.
Fundamentals of International Pharmaceutical and Biologics Regulations
Author | : Gloria Hall |
Publsiher | : Unknown |
Total Pages | : 135 |
Release | : 2018-09-04 |
Genre | : Electronic Book |
ISBN | : 1947493213 |
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