{"product_id":"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\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eFDA Regulatory Affairs\u003c\/em\u003e\u003c\/strong\u003e:\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eprovides a blueprint to the FDA and drug, biologic, and medical device development\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eoffers current, real-time information in a simple and concise format\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003econtains a chapter highlighting the new drug application (NDA) process\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003ediscusses FDA inspection processes and enforcement options\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\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\n\u003cp\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003c\/ul\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThree all-new chapters cover:\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eclinical trial exemptions\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eadvisory committees\u003c\/li\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eprovisions for fast track\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Taylor \u0026 Francis","offers":[{"title":"Default Title","offer_id":48534045753585,"sku":"9781420073546","price":280.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0674\/5433\/7265\/files\/9781420073546_p0.jpg?v=1786329302","url":"https:\/\/shop.barnesandnoble.com\/products\/9781420073546","provider":"Barnes \u0026 Noble","version":"1.0","type":"link"}