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The FDA for Doctors
by William H. EaglsteinMany doctors want to know more about the FDA not only so that they might better understand the issues and how they are related to their practice, such as off label-drug usage, but also to enrich their professional lives and allow them to more deeply understand the many FDA related articles written in the popular press It is further based on the notion that doctors prefer a formal way to learn about FDA. The Agency is a truly vast subject engaging thousands of lawyers, regulators, scientists, physicians, writers, legislators and many others directly and indirectly. This book is an introductory overview written from a physician's perspective for physicians It is organized along lines that emphasize issues most interesting to physicians. Much of it deals with nomenclature and definitions, since as is true of all fields, one must understand the special concepts and vocabulary of the field.
FDI, Regionalism, Government Policy and Endogenous Growth: A Comparative Study of the ASEAN-5 Economies, with Development Policy Implications for the Least Developed Countries
by Anthony Bende-NabendePublished in 1999, this text investigates whether FDI caused spill over effects which have led to the economic growth of the ASEAN-5 economies, and if that it so, whether the ASEAN Preferential Trade Agreement (APTA) had a significant effect in attracting FDI to the region. It takes into account the different levels of economic development of the countries under analysis. The results from the structural (static) model suggest that FDI has stimulated economic growth through the human factors followed by technology transfer, international trade, and learning by doing, and that the formation of APTA had a lagged influence on FDI inflows into the advantage of the more developed member countries and the disadvantage of the less developed countries. Those from the multiplier (dynamic) effects analysis demonstrate that whereas the impact is immediate in the more developed, politically stable and foreign investment friendly economies, there is a time lag in those economies which are less developed and more hostile to FDI. The analysis presents an empirical comparison of how the level of economic development affects the interaction of FDI, regionalism and economic growth.
FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies
by Lynch Holly Fernandez Cohen I. GlennIn its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
FDA in the Twenty-First Century
by Holly Fernandez Lynch I. Glenn CohenIn its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.
FDR
by Jean Edward SmithOne of today's premier biographers has written a modern, comprehensive, indeed ultimate book on the epic life of Franklin Delano Roosevelt. In this superlative volume, Jean Edward Smith combines contemporary scholarship and a broad range of primary source material to provide an engrossing narrative of one of America's greatest presidents.This is a portrait painted in broad strokes and fine details. We see how Roosevelt's restless energy, fierce intellect, personal magnetism, and ability to project effortless grace permitted him to master countless challenges throughout his life. Smith recounts FDR's battles with polio and physical disability, and how these experiences helped forge the resolve that FDR used to surmount the economic turmoil of the Great Depression and the wartime threat of totalitarianism. Here also is FDR's private life depicted with unprecedented candor and nuance, with close attention paid to the four women who molded his personality and helped to inform his worldview: His mother, Sara Delano Roosevelt, formidable yet ever supportive and tender; his wife, Eleanor, whose counsel and affection were instrumental to FDR's public and individual achievements; Lucy Mercer, the great romantic love of FDR's life; and Missy LeHand, FDR's longtime secretary, companion, and confidante, whose adoration of her boss was practically limitless. Smith also tackles head-on and in-depth the numerous failures and miscues of Roosevelt's public career, including his disastrous attempt to reconstruct the Judiciary; the shameful internment of Japanese-Americans; and Roosevelt's occasionally self-defeating Executive overreach. Additionally, Smith offers a sensitive and balanced assessment of Roosevelt's response to the Holocaust, noting its breakthroughs and shortcomings.Summing up Roosevelt's legacy, Jean Smith declares that FDR, more than any other individual, changed the relationship between the American people and their government. It was Roosevelt who revolutionized the art of campaigning and used the burgeoning mass media to garner public support and allay fears. But more important, Smith gives us the clearest picture yet of how this quintessential Knickerbocker aristocrat, a man who never had to depend on a paycheck, became the common man's president. The result is a powerful account that adds fresh perspectives and draws profound conclusions about a man whose story is widely known but far less well understood. Written for the general reader and scholars alike, FDR is a stunning biography in every way worthy of its subject.From the Hardcover edition.
FDR
by Jean Edward SmithOne of today's premier biographers has written a modern, comprehensive, indeed ultimate book on the epic life of Franklin Delano Roosevelt. In this superlative volume, Jean Edward Smith combines contemporary scholarship and a broad range of primary source material to provide an engrossing narrative of one of America's greatest presidents. This is a portrait painted in broad strokes and fine details. We see how Roosevelt's restless energy, fierce intellect, personal magnetism, and ability to project effortless grace permitted him to master countless challenges throughout his life. Smith recounts FDR's battles with polio and physical disability, and how these experiences helped forge the resolve that FDR used to surmount the economic turmoil of the Great Depression and the wartime threat of totalitarianism. Here also is FDR's private life depicted with unprecedented candor and nuance, with close attention paid to the four women who molded his personality and helped to inform his worldview: His mother, Sara Delano Roosevelt, formidable yet ever supportive and tender; his wife, Eleanor, whose counsel and affection were instrumental to FDR's public and individual achievements; Lucy Mercer, the great romantic love of FDR's life; and Missy LeHand, FDR's longtime secretary, companion, and confidante, whose adoration of her boss was practically limitless. Smith also tackles head-on and in-depth the numerous failures and miscues of Roosevelt's public career, including his disastrous attempt to reconstruct the Judiciary; the shameful internment of Japanese-Americans; and Roosevelt's occasionally self-defeating Executive overreach. Additionally, Smith offers a sensitive and balanced assessment of Roosevelt's response to the Holocaust, noting its breakthroughs and shortcomings. Summing up Roosevelt's legacy, Jean Smith declares that FDR, more than any other individual, changed the relationship between the American people and their government. It was Roosevelt who revolutionized the art of campaigning and used the burgeoning mass media to garner public support and allay fears. But more important, Smith gives us the clearest picture yet of how this quintessential Knickerbocker aristocrat, a man who never had to depend on a paycheck, became the common man's president. The result is a powerful account that adds fresh perspectives and draws profound conclusions about a man whose story is widely known but far less well understood. Written for the general reader and scholars alike,FDRis a stunning biography in every way worthy of its subject. From the Hardcover edition.
FDR and Civil Aviation
by Alan P. DobsonThe aim of this study is to demonstrate that Franklin D. Roosevelt was one of the leading agents in both setting out and working to implement the principles that came to govern the international aviation system from 1945 down to the recent present and that much of its design was drawn from the experience of domestic US aviation reform in the 1930s. In contemporary parlance one might say that what is proposed here is the explanation of the genesis of a roadmap set out successively by Roosevelt's administrations for the achievement of a liberalized and lightly regulated international civil aviation market. Furthermore, a key contention of this research is that FDR himself played a much more important role in crafting policy than has previously been acknowledged.
FDR and Lucy: Lovers and Friends
by Resa WillisFirst Published in 2005. Routledge is an imprint of Taylor & Francis, an informa company.
FDR and the American Crisis
by Albert MarrinThe definitive biography of president Franklin Delano Roosevelt for young adult readers, from National Book Award finalist Albert Marrin. Brought up in a privileged family, Franklin Delano Roosevelt had every opportunity in front of him. As a young man, he found a path in politics and quickly began to move into the public eye. That ascent seemed impossible when he contracted polio and lost the use of his legs. But with a will of steel he fought the disease--and public perception of his disability--to become president of the United States of America. FDR used that same will to guide his country through a crippling depression and a horrendous world war. He understood Adolf Hitler, and what it would take to stop him, before almost any other world leader did. But to accomplish his greater goals, he made difficult choices that sometimes compromised the ideals of fairness and justice. FDR is one of America's most intriguing presidents, lionized by some and villainized by others. National Book Award finalist Albert Marrin explores the life of a fascinating, complex man, who was ultimately one of the greatest leaders our country has known.
FDR and the End of Empire: The Origins of American Power in the Middle East (The World of the Roosevelts)
by Christopher D. O’SullivanBased upon extensive archival research in Great Britain, the United States, and the Middle East, including sources never previously utilized such as declassified intelligence records, postwar planning documents, and the personal papers of key officials, this is painstakingly researched account of the origins of American involvement in the Middle East during the Presidency of Franklin D. Roosevelt. It explores the effort to challenge British and French power, and the building of new relationships with Iraq, Iran, Saudi Arabia, Egypt, and the Levant states. It also reveals new and controversial discoveries about Roosevelt's views on Palestine, his relations with Middle East leaders, and his often bitter conflicts with Churchill and de Gaulle over European imperialism. Modern-day parallels make this story compelling for followers of current events, World War II, Franklin Roosevelt, the Middle East, or British imperialism.
FDR and the Jews
by Richard Breitman Allan J. LichtmanA contentious debate lingers over whether Franklin Delano Roosevelt turned his back on the Jews of Hitler’s Europe. FDR and the Jews reveals a concerned leader whose efforts on behalf of Jews were far greater than those of any other world figure but whose moral leadership was tempered by the political realities of depression and war.
FDR and the New Deal for Beginners®
by Paul BuhleA profusely illustrated, popularly-written volume with original comic art,FDR and The New Deal For Beginnerswill shed new light upon a story now regaining visibility thanks to the recent economic crisis and prominent reformer, President Obama, in the White House. The history of the precedent-making FDR administration through the bitter economic depression, with expansive programs empowering artists and working people, comes alive as the grandest social experiment in the history of American democracy. ...
FDR and the Spanish Civil War: Neutrality and Commitment in the Struggle that Divided America
by Dominic TierneyWhat was the relationship between President Franklin D. Roosevelt, architect of America's rise to global power, and the 1936-39 Spanish Civil War, which inspired passion and sacrifice, and shaped the road to world war? While many historians have portrayed the Spanish Civil War as one of Roosevelt's most isolationist episodes, Dominic Tierney argues that it marked the president's first attempt to challenge fascist aggression in Europe. Drawing on newly discovered archival documents, Tierney describes the evolution of Roosevelt's thinking about the Spanish Civil War in relation to America's broader geopolitical interests, as well as the fierce controversy in the United States over Spanish policy. Between 1936 and 1939, Roosevelt's perceptions of the Spanish Civil War were transformed. Initially indifferent toward which side won, FDR became an increasingly committed supporter of the leftist government. He believed that German and Italian intervention in Spain was part of a broader program of fascist aggression, and he worried that the Spanish Civil War would inspire fascist revolutions in Latin America. In response, Roosevelt tried to send food to Spain as well as illegal covert aid to the Spanish government, and to mediate a compromise solution to the civil war. However unsuccessful these initiatives proved in the end, they represented an important stage in Roosevelt's emerging strategy to aid democracy in Europe.
FDR At War: The Mantle of Command, Commander in Chief, and War and Peace (Fdr At War Ser. #3)
by Nigel HamiltonThe definitive three-volume history that FDR did not live to write: the story of World War II from his perspective, showing his mastery of strategy, his vision, and how he overcame resistance from Churchill and his own generals to set the course for victory. Mantle of Command, Commander in Chief, and War and Peace have been celebrated as "masterly" (The Wall Street Journal).
FDR, Dewey, and the Election of 1944
by David M. JordanAlthough the presidential election of 1944 placed FDR in the White House for an unprecedented fourth term, historical memory of the election itself has been overshadowed by the war, Roosevelt's health and his death the following April, Truman's ascendancy, and the decision to drop the atomic bomb. Today most people assume that FDR's reelection was assured. Yet, as David M. Jordan's engrossing account reveals, neither the outcome of the campaign nor even the choice of candidates was assured. Just a week before Election Day, pollster George Gallup thought a small shift in votes in a few key states would award the election to Thomas E. Dewey. Though the Democrats urged voters not to "change horses in midstream," the Republicans countered that the war would be won "quicker with Dewey and Bricker." With its insider tales and accounts of party politics, and campaigning for votes in the shadow of war and an uncertain future, FDR, Dewey, and the Election of 1944 makes for a fascinating chapter in American political history.
FDR Goes to War
by Anita Folsom Burton W. FolsomFrom the acclaimed author of New Deal or Raw Deal?, called "eye-opening" by the National Review, comes a fascinating exposé of Franklin Delano Roosevelt's destructive wartime legacy--and its adverse impact on America's economic and foreign policies today. Did World War II really end the Great Depression--or did President Franklin Roosevelt's poor judgment and confused management leave Congress with a devastating fiscal mess after the final bomb was dropped? In this provocative new book, historians Burton W. Folsom, Jr., and Anita Folsom make a compelling case that FDR's presidency led to evasive and self-serving wartime policies. At a time when most Americans held isolationist sentiments--a backlash against the stunning carnage of World War I--Roosevelt secretly favored an aggressive interventionist foreign policy. Yet, throughout the 1930s, he spent lavishly on his disastrous New Deal programs and slashed defense spending, leaving America vastly unprepared for Japan's attack on Pearl Harbor and the challenge of fighting World War II. History books tell us the wartime economy was a boon, thanks to massive government spending. But the skyrocketing national debt, food rations, nonexistent luxuries, crippling taxes, labor strikes, and dangerous work of the time tell a different story--one that is hardly the stuff of recovery. Instead, the war ushered in a new era of imperialism for the executive branch. Roosevelt seized private property, conducted illegal wiretaps, tried to silence domestic opposition, and interned 110,000 Japanese Americans. He set a dangerous precedent for entangling alliances in foreign affairs, including his remarkable courtship of Russian dictator Joseph Stalin, while millions of Americans showed the courage, perseverance, and fortitude to make the weapons and fight the war. Was Roosevelt a great wartime leader, as historians almost unanimously assert? The Folsoms offer a thought-provoking revision of his controversial legacy. FDR Goes to War will make America take a second look at one of its most complicated presidents.
FDR in American Memory: Roosevelt and the Making of an Icon
by Sara PolakHow was FDR's image constructed—by himself and others—as such a powerful icon in American memory?In polls of historians and political scientists, Franklin Delano Roosevelt consistently ranks among the top three American presidents. Roosevelt enjoyed an enormous political and cultural reach, one that stretched past his presidency and across the world. A grand narrative of Roosevelt's crucial role in the twentieth century persists: the notion that American ideology, embodied by FDR, overcame the Depression and won World War II, while fascism, communism, and imperialism—and their ignoble figureheads—fought one another to death in Europe. This grand narrative is flawed and problematic, legitimizing the United States's cultural, diplomatic, and military role in the world order, but it has meant that FDR continues to loom large in American culture.In FDR in American Memory, Sara Polak analyzes Roosevelt's construction as a cultural icon in American memory from two perspectives. First, she examines him as a historical leader, one who carefully and intentionally built his public image. Focusing on FDR's use of media and his negotiation of the world as a disabled person, she shows how he consistently aligned himself with modernity and future-proof narratives and modes of rhetoric. Second, Polak looks at portrayals and negotiations of the FDR icon in cultural memory from the vantage point of the early twenty-first century. Drawing on recent and well-known cultural artifacts—including novels, movies, documentaries, popular biographies, museums, and memorials—she demonstrates how FDR positioned himself as a rhetorically modern and powerful but ideologically almost empty container. That deliberate positioning, Polak writes, continues to allow almost any narrative to adopt him as a relevant historical example even now.As a study of presidential image-fashioning, FDR in American Memory will be of immediate relevance to present-day readers.
FDR on Democracy: The Greatest Speeches and Writings of President Franklin Delano Roosevelt
by Harvey J. KayeFrom One of the Greatest Leaders in American History, a Collection of the Words and Writings that Inspired a Generation of Americans to Become the Greatest Generation In just under three decades of public life, Franklin Delano Roosevelt rose to become one of the greatest orators and leaders in American history. As the longest-serving US president, he guided the nation through two of the greatest challenges of the twentieth century—the Great Depression of the 1930s and the Fascist threat of the 1940s—and radically transformed American public life. In doing so, FDR created the conditions that enabled Americans to make the United States stronger, more prosperous, and more democratic than ever before for generations to come. Through his words—selected, annotated, and introduced here by writer and scholar Harvey J. Kaye—we rediscover the liberal and social-democratic vision and promise that FDR articulated so powerfully. We recall Roosevelt's efforts to redeem the challenge of the Declaration of Independence and renew the promise of equality and life, liberty, and the pursuit of happiness. We see him empower working people and make life more secure for more Americans. And we are reminded of his desire to not simply win the Second World War, but to create a nation and a world committed to the realization of the Four Freedoms—freedom of speech and worship, freedom from want and fear—indeed, to enact here in the United States a Second Bill of Rights, an Economic Bill of Rights for all Americans. In this collection of his greatest writings and speeches, we encounter the words that inspired and encouraged Americans to remember who they were and what they were capable of accomplishing—the words that helped turn a generation of Americans into the Greatest Generation. Now more than ever, we need to recall FDR's words. Now, when FDR's democratic legacy—the legacy of a generation—is under siege, we need to remind ourselves of who we are and what we need to do to make America freer, more equal, and more democratic.
FDR's Alphabet Soup: New Deal America, 1932-1939
by Tonya BoldenFDR’S New Deal, which followed the 1929 stock market crash, was a hugely influential moment in the history of the United States, encompassing everything from the arts to finance, labor to legislation, and some think it helped bring the country out of the Great Depression. Here, Tonya Bolden, writing in her trademark accessible style, creates a portrait of a time that changed American history both then and now. <P><P> FDR’s First 100 Days and how the United States was changed by it then are closely examined, especially now. The 2009 financial situation is eerily mirrored by that of the late 1920s, and this is a perfect book to help teens understand history and its lasting impact on current events.
FDR's Ambassadors and the Diplomacy of Crisis
by David MayersWhat effect did personality and circumstance have on US foreign policy during World War II? This incisive account of US envoys residing in the major belligerent countries - Japan, Germany, Italy, China, France, Great Britain, USSR - highlights the fascinating role played by such diplomats as Joseph Grew, William Dodd, William Bullitt, Joseph Kennedy and W. Averell Harriman. Between Hitler's 1933 ascent to power and the 1945 bombing of Nagasaki, US ambassadors sculpted formal policy - occasionally deliberately, other times inadvertently - giving shape and meaning not always intended by Franklin D. Roosevelt or predicted by his principal advisors. From appeasement to the Holocaust and the onset of the Cold War, David Mayers examines the complicated interaction between policy, as conceived in Washington, and implementation on the ground in Europe and Asia. By so doing, he also sheds needed light on the fragility, ambiguities and enduring urgency of diplomacy and its crucial function in international politics.
FDR's Budgeteer and Manager-in-Chief: Harold D. Smith, 1939-1945
by Mordecai LeeIn this book, Mordecai Lee provides a long-overdue examination of a key member of FDR's administration. Harold D. Smith was FDR's budget director from 1939 through to Roosevelt's death in 1945. In that capacity, he was also the de facto manager-in-chief of the federal government. During his tenure, he reformed and expanded the Bureau of the Budget (now Office of Management and Budget) into an elite cadre of apolitical experts dedicated to serving the institutionalized presidency. He pursued management reforms, reorganization, policymaking, economic planning, public relations, and a pinch of politics. In addition, Smith was a leader in professionalizing the emerging field of public administration, cofounding the American Society for Public Administration in 1939 and serving as its second president. A major figure in his time, he appeared on the cover of Time magazine in 1943, and FDR considered him irreplaceable. In response to Smith's offer to resign in 1944, Roosevelt lightheartedly replied, "I would no more accept your resignation than fly by jumping off a roof. You are essentially persona grata and doing a grand job. If you talk any more about resigning, I will act. A Marine Guard from Quantico will be stationed at your side during every minute of every twenty-four hours."
FDR's Folly: How Roosevelt and His New Deal Prolonged the Great Depression
by Jim Powell"Admirers of FDR credit his New Deal with restoring the American economy after the disastrous contraction of 1929-33. Truth to tell--as Powell demonstrates without a shadow of a doubt--the New Deal hampered recovery from the contraction, prolonged and added to unemployment, and set the stage for ever more intrusive and costly government. Powell's analysis is thoroughly documented, relying on an impressive variety of popular and academic literature both contemporary and historical." -Milton Friedman, Nobel Laureate, Hoover Institution. "There is a critical and often forgotten difference between disaster and tragedy. Disasters happen to us all, no matter what we do. Tragedies are brought upon ourselves by hubris. The Depression of the 1930s would have been a brief disaster if it hadn't been for the national tragedy of the New Deal. Jim Powell has proven this." -P. J. O'Rourke, author of Parliament of Whores and Eat the Rich. "The material laid out in this book desperately needs to be available to a much wider audience than the ranks of professional economists and economic historians, if policy confusion similar to the New Deal is to be avoided in the future." -James M. Buchanan, Nobel Laureate, George Mason University. "I found Jim Powell's book fascinating. I think he has written an important story, one that definitely needs telling." -Thomas Fleming, author of The New Dealers' War. "Jim Powell is one tough-minded historian, willing to let the chips fall where they may. That's a rare quality these days, hence more valuable than ever. He lets the history do the talking." -David Landes, Professor of History Emeritus, Harvard University. "Jim Powell draws together voluminous economic research on the effects of all of Roosevelt's major policies. Along the way, Powell gives fascinating thumbnail sketches of the major players. The result is a devastating indictment, compellingly told. Those who think that government intervention helped get the U. S. economy out of the depression should read this book." -David R. Henderson, editor of The Fortune Encyclopedia of Economics and author of The Joy of Freedom. The Great Depression and the New Deal. For generations, the collective American consciousness has believed that the former ruined the country and the latter saved it. Endless praise has been heaped upon President Franklin Delano Roosevelt for masterfully reining in the Depression's destructive effects and propping up the country on his New Deal platform. In fact, FDR has achieved mythical status in American history and is considered to be, along with Washington, Jefferson, and Lincoln, one of the greatest presidents of all time. But would the Great Depression have been so catastrophic had the New Deal never been implemented? In FDR's Folly, historian Jim Powell argues that it was in fact the New Deal itself, with its shortsighted programs, that deepened the Great Depression, swelled the federal government, and prevented the country from turning around quickly. You'll discover in alarming detail how FDR's federal programs hurt America more than helped it, with effects we still feel today, including: * How Social Security actually increased unemployment * How higher taxes undermined good businesses * How new labor laws threw people out of work * And much more.
FDR's Good Neighbor Policy: Sixty Years of Generally Gentle Chaos
by Fredrick B. PikeDuring the 1930s, the United States began to look more favorably on its southern neighbors. Latin America offered expanded markets to an economy crippled by the Great Depression, while threats of war abroad nurtured in many Americans isolationist tendencies and a desire for improved hemispheric relations. One of these Americans was Franklin Delano Roosevelt, the primary author of America’s Good Neighbor Policy. In this thought-provoking book, Fredrick Pike takes a wide-ranging look at FDR’s motives for pursuing the Good Neighbor Policy, at how he implemented it, and at how its themes have played out up to the mid-1990s. Pike’s investigation goes far beyond standard studies of foreign and economic policy. He explores how FDR’s personality and Eleanor Roosevelt’s social activism made them uniquely simpático to Latin Americans. He also demonstrates how Latin culture flowed north to influence U.S. literature, film, and opera. The book will be essential reading for everyone interested in hemispheric relations.