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When a problem arises with a product regulated by FDA, the Agency
can take a number of actions to protect the public health.
Initially, the agency works with the manufacturer to correct the
problem voluntarily. If that fails, administrative enforcement and
legal remedies include asking the manufacturer to recall a product
and having federal marshals seize products if a voluntary recall is
not done. Drugs can be seized and medical devices can be detained
and imports can be stopped at the port of entry until problems are
corrected. If warranted, FDA can ask the courts to issue
injunctions or prosecute those that deliberately violate the law.
When warranted, criminal penalties-including prison sentences-are
sought. Ensuring that your company is in compliance at all times in
all departments is a never-ending task. Failure to get it right,
even once, can mean excessive fines, penalties, or possible
debarment. The FDA Administrative Enforcement Manual explores the
control of drug research in pharmaceutical, vaccine, biologic,
biotechnology, medical device, and cosmeceutical industries.
Introducing basic industry techniques, the author explores every
day industry problems and presents suggested methods for applying
the theory to resolve them. The book covers the ten critical
Administrative Enforcement areas, including recalls, application
integrity, injunctions, seizures, and more. It supplements these
topics with regulations, lawsuit case studies, enforcement
information, and reference materials. Offering insight into the
impact of FDA enforcement on the national and international
pharmaceutical industry, practitioners and industry suppliers, the
book provides an understanding of drug development and
manufacturing regulations in the United States and shows you what
it takes to keep your company in compliance. The only complete,
single source available, the FDA Administrative Enforcement Manual
draws on the author's experience in the trenches of the
pharmaceutical industry with administrative enforcement activities.
Octavia E. Butler is widely recognized today as one of the most
important figures in contemporary science fiction. Bringing
together leading and emerging scholars and covering Butler’s
complete works from the bestselling novel Kindred, to her short
stories and major novel sequences Patternmaster, Xenogenesis and
The Parables, this is the most comprehensive Companion to Butler
scholarship available today. The Bloomsbury Handbook to Octavia E.
Butler covers the full range of contemporary scholarly themes and
approaches to the author’s work, including: · Cyborgs and the
posthuman · Race and African American history · Afrofuturism ·
Gender and sexuality · New perspectives from Religious Studies,
the Environmental Humanities and Disability Studies · New
discoveries from the Butler archives at the Huntington Library The
book includes a comprehensive bibliography of works by Butler and
secondary scholarship on her work as well as an afterword by the
novelist Tananarive Due.
This book explores an innovative study of women who undergo
cosmetic study and the doctors who carry it out. It situates
cosmetic surgery as a personal choice made by women against the
social and cultural reality of the way women's bodies are
scrutinised in Western countries.
This book explores an innovative study of women who undergo
cosmetic study and the doctors who carry it out. It situates
cosmetic surgery as a personal choice made by women against the
social and cultural reality of the way womens bodies are
scrutinised in Western countries.
The author discusses whether time travel is scientifically
possible. He examines "the history of the development of general
relativity, the conceptof curved space-time and the early evolution
of the universe. The remainder of the book seeks to] explain the
problems that arise when we attempt to turntheoretical holes in
space-time into time machines." (N Y Times Book Review)
I remember once watching a presentation of the creation of the
universe in a planetarium. It was a fascinating experience: lights
flashing, particles appearing to rush by as an explosive roar
echoed throughout the planetarium. Then suddenly ... black ness.
And after a few seconds ... tiny lights--stars blinking into
existence. I tried to imagine myself actually going back to this
event. Was this really what it was like? It was an interesting
facsimile, but far from what the real thing would have been like.
The creation of the universe is an event that is impossible to
imagine accurately. Fortunately, this has not discouraged peo ple
from wondering what it was like. In Creation I have attempted to
take you back to the begin ning-the big bang explosion-so that you
can watch the uni verse grow and evolve. Starting with the first
fraction of a sec ond, I trace the universe from its initial
dramatic expansion through to the formation of the first nuclei and
atoms. From here I go to the formation of galaxies and the curious
distribu tion they have taken in space. Finally I talk about the
formation of elements in stars, and the first life on the planets
around them.
By analyzing how America’s greatest presidents displayed their
mastery of statecraft, American Presidents in Diplomacy and War
offers important lessons about the most effective uses of national
power abroad. American Presidents in Diplomacy and War chronicles
the major foreign policy crises faced by twelve American presidents
in order to uncover the reoccurring patterns of successful and less
successful uses of diplomatic, economic, and military power. In
this brief and highly readable book, Thomas Parker reveals how
America’s most successful leaders manage events instead of
allowing events to control them. Parker explores how the U.S.
presidency, from the days of the early Republic to the present,
shaped the world. Ranging from George Washington to George H. W.
Bush, Parker shows how successful statecraft requires the
understanding of complex situations, the prudent evaluation of
various courses of action, the ability to adapt and to anticipate,
and personal determination. Parker compares each of these leaders
to their contemporaries—reasonable political leaders who
nonetheless made serious mistakes, such as Thomas Jefferson and
Barack Obama—to examine the dangers of being unable to strike the
right balance of aggressiveness and caution and to examine the
costs of inexperience and ambivalence toward military power. The
book concludes by discussing the increasingly complex international
situation of today, particularly the manifold challenges posed by
China and Russia to U.S. foreign policy, and the continued
necessity of effective statecraft.
Octavia E. Butler is widely recognized today as one of the most
important figures in contemporary science fiction. Bringing
together leading and emerging scholars and covering Butler's
complete works from the bestselling novel Kindred, to her short
stories and major novel sequences Patternmaster, Xenogenesis and
The Parables, this is the most comprehensive Companion to Butler
scholarship available today. The Bloomsbury Handbook to Octavia E.
Butler covers the full range of contemporary scholarly themes and
approaches to the author's work, including: * Cyborgs and the
posthuman * Race and African American history * Afrofuturism *
Gender and sexuality * New perspectives from Religious Studies, the
Environmental Humanities and Disability Studies * New discoveries
from the Butler archives at the Huntington Library The book
includes a comprehensive bibliography of works by Butler and
secondary scholarship on her work as well as an afterword by the
novelist Tananarive Due.
Contrary to what news reports might suggest, the majority of
politicians behave ethically and are never subject to
investigations. Is this because of the elaborate system of rules
Congress has constructed to regulate the conduct of its members as
well as the fear of electoral reprisal? Drawing on economic
literature on the behavior of firms, Glenn Parker answers no. He
argues that members of Congress behave ethnically not because of
the fear of punishment but because of their concern for their
reputations. He draws parallels between politicians and businesses,
since both stand to suffer significantly when accused of
wrongdoing.
Just as business' poor behavior can cause brand names to be
tarnished, prices to plummet, and future business to disappear,
dishonest politicians stand to sacrifice the human capital invested
in their careers, and premiums for honesty, such as electoral
security and prestigious post-elective employment. Parker explores
public attitudes toward the behavior of members of Congress and
shows how those attitudes shape the way members conduct their
professional lives. Written from the perspective of public choice,
this book offers a novel approach to the question of how to keep
politicians honest.
This book is an introduction to programming concepts that uses
Python 3 as the target language. It follows a practical just in
time presentation - material is given to the student when it is
needed. Many examples will be based on games because Python has
become the language of choice for basic game development. Designed
as a year 1 textbook for introduction to programming classes or for
the hobbyist who wants to learn the fundamentals of programming,
the text assumes no programming experience. FEATURES: Introduces
programming concepts using Python 3. Covers basic computer concepts
such as loops, strings, functions, files, graphics, multimedia,
algorithms, classes, writing code, etc. Develops graphics,
exercises, and user interface using Pygame. Includes many examples
based on video game development. 4 color throughout with game demos
on the companion files. New chapters on parsing (14) and graphics
(15). Instructor ancillaries for use as a textbook.
This book is an introduction to programming concepts that uses
Python 3 as the target language. It follows a practical
just-in-time presentation - material is given to the student when
it is needed. Many examples will be based on games, because Python
has become the language of choice for basic game development.
Designed as a Year One textbook for introduction to programming
classes or for the hobbyist who wants to learn the fundamentals of
programming, the text assumes no programming experience. Features:
Introduces programming concepts that use Python 3 Includes many
examples based on video game development 4-color throughout with
game demos on the companion files
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The Back Burner (Paperback)
Yolanda R Parker; Edited by Yvette Wiggins; Illustrated by Robyn Brown
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R666
Discovery Miles 6 660
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Ships in 10 - 15 working days
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The crisis of Spartan power in the first half of the fourth
century has been connected to Spartan inability to manage the
hegemony built on the ruins of the Athenian Empire, or interpreted
as a result of the unexpected annihilation of the Spartan army by
the Boeotians at Leuktra. The present book offers a new
perspective, suggesting that the crisis that finally brought down
Sparta was in important ways a result of centrifugal impulses
within the Peloponnesian League, accompanied by a general awakening
of ethnicity in various areas of the Peloponnese.
A series of regional case studies is combined with thematic
contributions focusing on topics such as the relationship of
religious cults and ethnicity and of democracy and ethnicity, the
use of archaeological evidence for ethnic phenomena, and
comparative approaches based on social anthropology.
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