{"product_id":"fda-regulatory-affairs-9781841849195","title":"FDA Regulatory Affairs","description":"\u003cp\u003eFDA 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 thats broadly useful to both business and academia.\u003c\/p\u003e","brand":"My Store","offers":[{"title":"Default Title","offer_id":45651955941429,"sku":"ByrdShop_1841849197","price":109.2,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0627\/8139\/0901\/files\/9781841849195.jpg?v=1781847434","url":"https:\/\/atxbooks.com\/products\/fda-regulatory-affairs-9781841849195","provider":"ATX Books","version":"1.0","type":"link"}