Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance

The COVID-19 pandemic has highlighted the crucial role regulation plays in the economy and society, but has also exposed gaps in domestic and international rule-making that have cost lives and money. The 2021 Regulatory Policy Outlook, the third in the series, maps country efforts to improve regulatory quality in line with the 2012 OECD Recommendation on Regulatory Policy and Governance, and shares good regulatory practices that can help close the gaps.

How regulations are implemented and enforced, and how compliance is ensured and promoted, are critical determinants of whether a regulatory system is working as intended. Inspections are one of the most important ways to enforce regulations and to ensure regulatory compliance. Based on the 2014 ...

A 2022 PROSE Award finalist in Legal Studies and Criminology A 2022 American Bar Association Silver Gavel Award Finalist A Behavioral Scientist’s Notable Book of 2021 Freakonomics for the law—how applying behavioral science to the law can fundamentally change and explain misbehavior Why do most Americans wear seatbelts but continue to speed even though speeding fines are higher? Why could park rangers reduce theft by removing “no stealing” signs? Why was a man who stole 3 golf clubs sentenced to 25 years in prison? Some laws radically change behavior whereas others are consistently ignored and routinely broken. And yet we keep relying on harsh punishment against crime despite its continued failure. Professors Benjamin van Rooij and Adam Fine draw on decades of research to uncover the behavioral code: the root causes and hidden forces that drive human behavior and our responses to society’s laws. In doing so, they present the first accessible analysis of behavioral jurisprudence, which will fundamentally alter how we understand the connection between law and human behavior. The Behavioral Code offers a necessary and different approach to battling crime and injustice that is based in understanding the science of human misconduct—rather than relying on our instinctual drive to punish as a way to shape behavior. The book reveals the behavioral code’s hidden role through illustrative examples like: • The illusion of the US’s beloved tax refund • German walls that “pee back” at public urinators • The $1,000 monthly “good behavior” reward that reduced gun violence • Uber’s backdoor “Greyball” app that helped the company evade Seattle’s taxi regulators • A $2.3 billion legal settlement against Pfizer that revealed how whistleblower protections fail to reduce corporate malfeasance • A toxic organizational culture playing a core role in Volkswagen’s emissions cheating scandal • How Peter Thiel helped Hulk Hogan sue Gawker into oblivion Revelatory and counterintuitive, The Behavioral Code catalyzes the conversation about how the law can effectively improve human conduct and respond to some of our most pressing issues today, from police misconduct to corporate malfeasance.

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.