FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

As the COVID-19 pandemic continues to take its toll, contractual parties have frequently faced significant obstacles in performing their contractual obligations due to unexpected impediments arising from the pandemic and government measures taken in response. This indispensable book – the most comprehensive comparative examination of the impact of the COVID-19 pandemic on contractual performance – discusses the legal provisions and doctrines available to address these issues. The book examines under what circumstances COVID-19-related impediments may excuse contractual performance or lead to modification or termination of the affected contractual obligations in twelve representative civil and common law jurisdictions – the United States, England and Wales, Singapore, Brazil, Germany, France, Switzerland, Austria, Hong Kong, Costa Rica, China, and Russia. For each country, the book examines the following aspects in depth: the relevant fundamental legal principles; the various legal emergency valves available to an obligor to respond to COVID-19-related events; any remedies available to the obligee; selected examples for specific government measures related to particular types of contracts (e.g., construction, employment, lease agreements); and how the legal framework applies in typical factual scenarios. As further legal and factual developments occur, and with further jurisdictions being added, this publication will continue to be updated both online and in print. The book provides a detailed explanation under what conditions the emergency valves specific to each jurisdiction may apply. It cuts through the seeming complexity of the various legal rules and doctrines in these jurisdictions and shows that they often produce similar results in practice. The book thus opens up a wealth of insights for businesses, practitioners, and academics around the globe by providing an easily accessible analytical framework across key jurisdictions and typical factual scenarios. ‘Definitely mandatory reading for practitioners and academics alike!’ –Klaus Peter Berger, University of Cologne ‘Everyone who has had or is likely to have a brush with a COVID-19-induced legal issue would be well advised to keep this book within arm’s reach.’ – Davinder Singh, Davinder Singh Chambers LLC, Singapore ‘The “holy book” for all those lawyers whose clients become ensnared in the rising attempts to fix legal liability midst the rampant COVID-19.’ – Charles Brower, Twenty Essex, London

In response to the call of the 48th World Health Assembly for a substantial revision of the International Health Regulations, this new edition of the Regulations will enter into force on June 15, 2007. The purpose and scope of the Regulations are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The Regulations also cover certificates applicable to international travel and transport, and requirements for international ports, airports and ground crossings.

The ultimate guide for anyone wondering how President Joe Biden will respond to the COVID-19 pandemic—all his plans, goals, and executive orders in response to the coronavirus crisis. Shortly after being inaugurated as the 46th President of the United States, Joe Biden and his administration released this 200 page guide detailing his plans to respond to the coronavirus pandemic. The National Strategy for the COVID-19 Response and Pandemic Preparedness breaks down seven crucial goals of President Joe Biden's administration with regards to the coronavirus pandemic: 1. Restore trust with the American people. 2. Mount a safe, effective, and comprehensive vaccination campaign. 3. Mitigate spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards. 4. Immediately expand emergency relief and exercise the Defense Production Act. 5. Safely reopen schools, businesses, and travel while protecting workers. 6. Protect those most at risk and advance equity, including across racial, ethnic and rural/urban lines. 7. Restore U.S. leadership globally and build better preparedness for future threats. Each of these goals are explained and detailed in the book, with evidence about the current circumstances and how we got here, as well as plans and concrete steps to achieve each goal. Also included is the full text of the many Executive Orders that will be issued by President Biden to achieve each of these goals. The National Strategy for the COVID-19 Response and Pandemic Preparedness is required reading for anyone interested in or concerned about the COVID-19 pandemic and its effects on American society.

International Arbitration and the COVID-19 Revolution Edited by Maxi Scherer, Niuscha Bassiri & Mohamed S. Abdel Wahab The impact of the COVID-19 pandemic on all major economic sectors and industries has triggered profound and systemic changes in international arbitration. Moreover, the fact that entire proceedings are now being conducted remotely constitutes so significant a deviation from the norm as to warrant the designation ‘revolution’. This timely book is the first to describe and analyse how the COVID-19 crisis has redefined arbitral practice, with critical appraisal from well-known practitioners of the pandemic’s effects on substantive and procedural aspects from the commencement of proceedings until the enforcement of the award. With practical guidance from a variety of perspectives – legal, practical, and sector-specific – on the conduct of international arbitration during the COVID-19 pandemic and beyond, the chapters present leading practitioners’ insights into the unprecedented and multifaceted issues that arise. They provide expert tips and challenges in such practical matters as the following: preventing and resolving disputes of particular types – construction, energy, aviation, technology, media and telecommunication, finance and insurance; arbitrator appointments; issues of planning, preparation and sample procedural orders; witness preparation and cross-examination; e-signature of arbitral awards; setting aside and enforcement proceedings; and third-party funding. Also included are an empirical survey of users’ views and an overview of how the COVID-19 revolution has affected the arbitration rules of leading arbitral seats. With this timely and practical book, arbitration practitioners and scholars will gain up-to-date knowledge of sector-specific challenges brought about by the COVID-19 pandemic and approach arbitration proceedings with an understanding of the most important legal and practical considerations during the crisis and beyond.

This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.