Editorial Reviews. Review. "This book covers the myriad of topics related to the development eBook features: Highlight, take notes, and search in the book; In this edition, page numbers are just like the physical edition; Length: pages; Format: Print. FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise. FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain.
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Written in plain language without confusing jargon or legalese, FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and. (ebook) FDA Regulatory Affairs from Dymocks online store. Since the enactment of the first drug law in , the. For Librarians Available on Taylor & Francis eBooks >> FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development.
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(ebook) FDA Regulatory Affairs
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FDA Regulatory Affairs
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A Guide for Prescription Drugs, Medical Devices, and Biologics
Your rating has been recorded. Write a review Rate this item: Preview this item Preview this item. Boca Raton FL: Taylor and Francis, . Third edition View all editions and formats Summary: 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.
Read more Allow this favorite library to be seen by others Keep this favorite library private. Find a copy in the library Finding libraries that hold this item Ressources Internet Additional Physical Format: Pisano, Douglas J. FDA Regulatory Affairs. Document, Internet resource Document Type: Find more information about: David Mantus Douglas J Pisano.
Examines harmonization of US Federal Food, and Cosmetic Act with international regulations as they apply to human drug and device development, research, and marketing. Focusing on drug approval process, cGMPs, GCPs, quality system compliance, and documentation requirements, this title is suitable for those involved in pharmaceutical regulation.
Reviews Editorial reviews. Publisher Synopsis "This book covers the myriad of topics related to the development and marketing of all types of drugs and devices regulated by the U. User-contributed reviews Add a review and share your thoughts with other readers. Be the first.
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