{"product_id":"fda-regulatory-affairs-douglas-j-pisano-9781420073546","title":"FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics","description":"\u003cp\u003eExamines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The \u003cem\u003e\u003cstrong\u003eSecond Edition\u003c\/strong\u003e\u003c\/em\u003e focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFDA Regulatory Affairs\u003c\/em\u003e\u003c\/strong\u003e: \u003c\/p\u003e\u003cul\u003e \u003cul\u003e \u003c\/ul\u003e \u003cli\u003eprovides a blueprint to the FDA and drug, biologic, and medical device development\u003c\/li\u003e \u003cli\u003eoffers current, real-time information in a simple and concise format\u003c\/li\u003e \u003cli\u003econtains a chapter highlighting the new drug application (NDA) process\u003c\/li\u003e \u003cli\u003ediscusses FDA inspection processes and enforcement options\u003c\/li\u003e \u003cli\u003eincludes contributions from experts at companies such as Millennium and Genzyme, leading CRO's such as PAREXEL and the Biologics Consulting Group, and the FDA\u003c\/li\u003e \u003cul\u003e \u003c\/ul\u003e \u003c\/ul\u003e\u003cp\u003eThree all-new chapters cover: \u003c\/p\u003e\u003cul\u003e \u003cul\u003e \u003c\/ul\u003e \u003cli\u003eclinical trial exemptions\u003c\/li\u003e \u003cli\u003eadvisory committees\u003c\/li\u003e \u003cli\u003eprovisions for fast track\u003c\/li\u003e \u003c\/ul\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Douglas J. Pisano\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1420073540\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781420073546\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 08\/11\/2008\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 464\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.70lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.10h x 6.20w x 1.10d","brand":"Douglas J. Pisano","offers":[{"title":"Hardcover","offer_id":48088202543359,"sku":"9781420073546","price":255.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_fa22ff49-8426-4933-87b5-8e1e3b36ed43.jpg?v=1769103626","url":"https:\/\/www.whiterainbookhouse.com\/products\/fda-regulatory-affairs-douglas-j-pisano-9781420073546","provider":"WR Book House","version":"1.0","type":"link"}