FDA Regulatory Affairs(English, Electronic book text, unknown) Offer
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- Language: English
- Binding: Electronic book text
- Publisher: Taylor & Francis Ltd
- Genre: Medical
- ISBN: 9781841849201, 9781841849201
- Pages: 400
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FDA Regulatory Affairs Specifications
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FDA Regulatory Affairs Features & Specifications stand apart in the LNDB6 : Making of rules & administrative acts category. The details about FDA Regulatory Affairs(English, Electronic book text, unknown) are given below as well. Unboxing FDA Regulatory Affairs specs Language: English, Binding: Electronic book text, Publisher: Taylor & Francis Ltd, Genre: Medical, ISBN: 9781841849201, 9781841849201, Pages: 400, & more details are given below
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.
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FDA Regulatory Affairs Specs
Book Details
| Title | FDA Regulatory Affairs |
| Imprint | CRC Press |
| Product Form | Electronic book text |
| Publisher | Taylor & Francis Ltd |
| Genre | Medical |
| ISBN13 | 9781841849201 |
| Book Category | Higher Education and Professional Books |
| BISAC Subject Heading | MED071000 |
| Book Subcategory | Applied Sciences and Other Technologies Books |
| ISBN10 | 9781841849201 |
| Language | English |
Books Info
| Language | English |
| Binding | Electronic book text |
| Pages | 400 |
| Publisher | Taylor & Francis Ltd |
| Year | 0 |
| Author | unknown |
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