This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.

COVID-19 is the most severe pandemic the world has experienced in a century. This book analyses major legal and regulatory responses internationally to COVID-19, and the impact the pandemic has had on human rights and freedoms, governance, the obligations of states and individuals, as well the role of the World Health Organization and other international bodies during this time. The authors examine notable legal challenges to public health measures enforced during the pandemic, such as lockdown orders, curfews, and vaccine mandates. Importantly, the book contextualizes the legal analysis by examining the broader social and economic dimensions of risks posed by the pandemic. The book considers how COVID-19 impacted the operation of the criminal justice system, civil litigation concerning negligently caused deaths and business losses arising from contractual breaches, consumer protection litigation, disciplinary regulation of health practitioners, coronial inquests and other investigations of unexpected deaths, and occupational health and safety issues. The book reflects on the role of the law in facilitating the remarkable scientific and epidemiological achievements during the pandemic, but also the challenges of ensuring the swift production and equitable distribution of treatments and vaccines. It concludes by considering the possibilities that the legal and regulatory responses to this pandemic have illuminated for effectively tackling future global health crises.

COVID-19 is the most severe pandemic the world has experienced in a century. This book analyses major legal and regulatory responses internationally to COVID-19, and the impact the pandemic has had on human rights and freedoms, governance, the obligations of states and individuals, as well the role of the World Health Organization and other international bodies during this time. The authors examine notable legal challenges to public health measures enforced during the pandemic, such as lockdown orders, curfews, and vaccine mandates. Importantly, the book contextualizes the legal analysis by examining the broader social and economic dimensions of risks posed by the pandemic. The book considers how COVID-19 impacted the operation of the criminal justice system, civil litigation concerning negligently caused deaths and business losses arising from contractual breaches, consumer protection litigation, disciplinary regulation of health practitioners, coronial inquests and other investigations of unexpected deaths, and occupational health and safety issues. The book reflects on the role of the law in facilitating the remarkable scientific and epidemiological achievements during the pandemic, but also the challenges of ensuring the swift production and equitable distribution of treatments and vaccines. It concludes by considering the possibilities that the legal and regulatory responses to this pandemic have illuminated for effectively tackling future global health crises.

This textbook surveys the major legal issues emanating from the policy responses to Covid-19 in the United States, with an emphasis on federalism, administrative law, and state and local government. The Covid-19 pandemic led to unprecedented policy responses from the various levels and organs of government in the United States, as well as from private parties. Business, school, and church closures, mask mandates, employer and university vaccine mandates, vaccine passports to visit movie theaters and restaurants — this panoply of responses changed the world many of us lived in and led to widespread and hotly contested litigation in America’s federal and state courts. In the first and only text of its kind, with carefully chosen case excerpts and summary information, The Law of Covid-19 highlights the key legal issues contested throughout the pandemic. Whether as a retrospective on what Covid wrought, a primer for future pandemics, or a supplement to a more general public health course, this text will help prepare you and your students for a world that will never be the same. Key Features: The Law of Covid-19 (“LC-19”) features carefully chosen and edited cases about public health authority at the federal and state levels. LC-19 focuses on the use of emergency authority by governors and mayors, including its impact on public employment and civil rights. LC-19 includes information on the federal and state health bureaucracies, including detailed recounting of the authorization and approval of the Covid-19 vaccines and boosters. Professors and students will benefit from: Organized discussion of the relevant sources of emergency and administrative authority at the federal and state levels. Thought-provoking questions and case notes that situate the relevant legal issues within the larger social and political context. A willingness to consider multiple perspectives, including those questioning whether the policy and legal response to Covid-19 may have been too draconian.

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.

In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

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.