Douglas J. Pisano - Böcker

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 marketingIncludes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXELFocuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirementsProvides 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) VExplains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissionsCo-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.

This book is a compilation and commentary of selected laws and regulations pertaining to the general practice of pharmacy in the United States. It is designed to be of assistance to practicing pharmacists, those seeking licensure by reciprocity, and other interested healthcare professionals.

Examines 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 Second Edition 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.FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device developmentoffers current, real-time information in a simple and concise formatcontains a chapter highlighting the new drug application (NDA) processdiscusses FDA inspection processes and enforcement optionsincludes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptionsadvisory committeesprovisions for fast track

This book is a compilation and commentary of selected laws and regulations pertaining to the general practice of pharmacy in the United States. It is designed to be of assistance to practicing pharmacists, those seeking licensure by reciprocity, and other interested healthcare professionals.