FDA Regulatory Affairs: Third Edition
- ISBN-10
- 1841849197
- ISBN-13
- 9781841849195
- Category
- Medical
- Pages
- 402
- Language
- English
- Published
- 2014-02-28
- Publisher
- CRC Press
- Authors
- Douglas J. Pisano, David Mantus
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.
Get the book
Other editions
-
- 2008-08-11
- 464 pages
- Paperback
- CRC Press
Similar books
-
How Institutions are Shaping the Future of Our Children: For Better or for Worse?
By Catherine Dulmus, Karen SowersLammert, M., & Timberlake, E. M. (1986). Termination of foster care for the older adolescent: Issues of emancipation and individuation.
-
Reversibility of Chronic Disease and Hypersensitivity, Volume 5: Treatment Options of Chemical Sensitivity
By William J. Rea, Kalpana D. PatelDou, L., E. Bertrand, C. Cerini, V. Faure, J. Sampol, R. Vanholder, Y. Berland, P. Brunet. ... A. Timberlake, B. Sumpio, R. Pfragner, I. M. Modlin, M. Kidd.
-
Rockwood and Green's Fractures in Adults
By William Ricci, Charles M. Court-Brown, Margaret M. McQueenChendrasekhar A, Moorman DW, Timberlake GA. An evaluation of the effects of ... Chittiboina P, Wylen E, Ogden A, et al. Traumatic spondylolisthesis of the ...
-
Breast Pathology, An Issue of Surgical Pathology Clinics
By Laura C. CollinsHartmann LC, Radisky DC, Frost MH, et al. Understanding the premalignant potential of ... D'Alfonso TM, Wang K, Chiu YL, et al. Pathologic upgrade rates on ...
-
Telepractice in Speech-Language Pathology
By K. Todd HoustonStensland, J., Speedie, S., Ideker, M., House, J., & Thompson, T. (1999). The relative cost of outpatient ... Deal, J. L. (1987). Appraisal and diagnosis of ...
-
Addressing Adversity: Prioritising adversity and trauma-informed care for children and young people in England.
By Marc Bush, Lord Victor Adebowale, Rebecca Adlington1 2 Howard, S. and Johnson, B. (2000) Resilient and Non-resilient Behaviour in ... 4 De Haan, L., Hawley, D. and Deal, J. (2002) 'Operationalizing family ...
-
Culture, Brain, and Analgesia: Understanding and Managing Pain in Diverse Populations
By Mario Incayawar, Knox H. Todd... are not fluent in the language/s of the medical care provider.72 Research ... Anglo-Americans have traditionally placed a great deal of emphasis on the ...
-
Image-Guided Spine Interventions
By John M. MathisThis practical guide thoroughly discusses both well-established and new interventions that are applied to the spine for the purpose of pain relief.
-
New Mynursinglab -- Access Card -- For Maternal-Child Nursing (24-Month Access)
By Pearson Education, Pearson Education, Inc., David P Pearson EducationSeveral versions of Pearson's MyLab & Mastering products exist for each title, including customized versions for individual schools, and registrations are not transferable.
-
Pearson's Medical Assisting (General)
By Pearson Education Staff, Madan Dr Pearson EducationIf a picture paints a thousand words, imagine what video can do? Pearson Medical Assisting Videos help users learn the nuances and the details of many medical assisting procedures.