[U292.Ebook] Download PDF DIY Bedroom Decor: 50 Awesome Ideas for Your Room, by Tana Smith

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DIY Bedroom Decor: 50 Awesome Ideas for Your Room, by Tana Smith

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Turn your dream bedroom into a reality!

Written by popular YouTube style expert Tana Smith, DIY Bedroom Decor teaches you how to personalize your space with all your favorite looks. From an Ombre Painted Canvas and Ribbon Chandelier to Chalkboard Frames and Sequin Curtains, this guide shows you how to create the fabulous room decor crafts that you've spotted in magazines and online on your Tumblr dashboard. With just a few simple tools and Smith's guidance, you'll turn your bedroom into a super cool space your friends will envy. Every page also includes step-by-step photographs that guide you through the process, so you'll never have to worry about how your projects will come out.

Filled with easy-to-follow instructions for 50 imaginative ideas, DIY Bedroom Decor helps you transform your current space into the bedroom of your dreams!

• Sales Rank: #590585 in Books
• Published on: 2015-06-01
• Original language: English
• Number of items: 1
• Dimensions: 8.20" h x .40" w x 8.30" l, .0 pounds
• Binding: Paperback
• 192 pages

Review

"Although marketed to a YA audience, there are plenty of easy-to-do projects here that will appeal to adult DIYers as well." --Library Journal

"Some teens and tweens don't care what their bedrooms look like. Some really, really do. Give that child, or even a college student confronted with a drab dorm room, DIY Bedroom Decor. If you have a style rebel in the house, this could be the book over which you put your heads together and have actual calm, happy conversations." --The Denver Post

"Whether you're making the big move into the dorms or just looking to spice up your bedroom, these insta-worthy DIYs are a game-changer for your blank walls!" --Justine Magazine

About the Author

Tana Smith is the creator of the popular fashion and lifestyle YouTube channel TanaMontana100. She was bitten by the creative bug when she was challenged with decorating her drab college dorm room. Now, she loves creating fun, inexpensive DIY projects that liven up any space. This is her first book.

Most helpful customer reviews

4 of 5 people found the following review helpful.
Sad
By J Serna
I cannot believe this book received 4 and 5 stars. Those reviews must be from the author herself or her publisher. Every single craft project in this book is unoriginal and woefully outdated. Sad looking wreaths, spray painted antlers for jewelry holder and a reindeer silhouette out of red buttons just to name a few. Don't waste your money.

4 of 5 people found the following review helpful.
The featured crafts are completely out-dated and not pretty. I cannot believe this book received 4 and ...
By Amazon Customer
Not worth your money. The featured crafts are completely out-dated and not pretty. I cannot believe this book received 4 and 5 stars! TERRIBLE!

0 of 0 people found the following review helpful.
Awesome and cool
By Rebecca
I think this book was great! It had so many great ideas and easy crafts in it!if your looking for simple ideas to amp up your room this is the book for you! Although, it said it had all a original ideas in it it did not. Some of these crafts I had seen before and others looked kind of weird.Overall it was a great book!

See all 10 customer reviews...

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[Q263.Ebook] Free Ebook Applying Communication Theory for Professional Life A Practical Introduction

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Applying Communication Theory for Professional Life A Practical Introduction by Dainton, Marianne, Zelley, Elaine D. Binding: Dawn. Published by SAGE Publications, Inc,2010, Binding: Paperback 2nd Edition

• Sales Rank: #11037418 in Books
• Binding: Paperback

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[C293.Ebook] Fee Download A Year Without Food: Discover the Unimaginable World of Proven Energetic Nourishment (Spiritual Energy for Healthy Life), by Ray Maor

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Can spirit really come over matter?Discover how some of your greater paradigms are broken, and reshape the way you view reality.

Can human life be sustained without food or on imaginable small quantities? The both scientifically researched and spiritual explained answer is in this book, but you will have to put aside many of today's current paradigms once you realize and feel the compelling evidence.

After years of spiritual development, in search of a higher understanding of our path, Ray Maor decided to take the ultimate consciousness leap. Trusting in just the air to catch him, he undertook the dangerous but transformative Breatharian initiation. The air carried him far.

As his soul and his body settled into this astounding way of living off the energy of Prana, he decided to go further again. In a world first television broadcast, he agreed to go for eight days without not just food, but water as well - while his every movement was filmed.

The Israeli film crew set up comprehensively ”big brothered’ living quarters with no privacy - at all, at any time! A senior medical specialist was brought in to review Ray every day. As well as mental state evaluation and a physical examination, bloods were taken daily. The doctor only agreed on the basis that he could make the final decision to abort the experiment if Ray was in danger. In line with current medical teaching, the doctor was confident that Ray would not survive more than a handful of days before dehydration caused his organs to begin to shut down.

This book is not just Ray’s personal account of this remarkable experiment.

From his uniquely Breatharian perspective, Ray shares his greater journey in order to promote our understanding of our spiritual-mental connection to our physical body.

If you are looking to float to new heights in your spiritual journey this book is for you. Ray’s insights will change the way you think about the world you live in. He dismantles the very foundations of how we think it all works ...

˃˃˃ This book is a must!

'It is not my wish for people to stop being nourished from food, it is my goal to open up their consciousness to the fact that they are already being nourished energetically in a perfect manner and have them relearn and relive their eating and drinking experience a new, higher awareness point of view of excitement and self-love.'

For those who seek a great understanding or those who are on self-development path, this book is a must.

Scroll up and grab a copy today.

• Sales Rank: #121986 in eBooks
• Published on: 2015-01-21
• Released on: 2015-01-21
• Format: Kindle eBook

Most helpful customer reviews

8 of 10 people found the following review helpful.
An Enlightening Read!!
By Melissa Corbeil (Inspired Leo Goddess)
A Year Without Food is Ray Maor's recount of his journey to becoming a Breatharian.This is an incredible way of life, using Prana as the soul's main life force. In a true Paradigm shift, Maor debunks the idea that man must eat and drink to survive.While there are concepts I can grasp through this book, such as emotional eating, I cannot imagine successfully turning away from food as nourishment.Maor does just this. He has the blood tests and good health to back up his claims. If you are looking for a fascinating glimpse into an alternate state of health and well being, this is a must read.While I cannot see myself becoming a Breatharian, I am glad I read this book as it has challenged my ideals and concepts of "healthy". There is no denying that we as a global body are unwell. Our portion sizes are out of control and this is reflected in the rising obesity rates.I cannot help but wonder if there is a happy medium here.
Eating to be healthy but not to fill emotional holes? This is an excellent read that will open your eyes and mind to a different way of life.
I received this book in exchange for an honest review. All opinions are my own.

5 of 6 people found the following review helpful.
Very disappointed when I expected a book about someone who had ...
By Chiang Mai
Very disappointed when I expected a book about someone who had not eaten for a year then discovered it was only days? completely inaccurate TITLE which is very unfair to customers expecting, and excited, to read about someone who had survived on Prana for a year.

8 of 11 people found the following review helpful.
Loved this Spiritual Journey!! A+
By Up Close and Caffeinated
**I received this free product to review. I was not required to write a positive review nor was I compensated in any other way. The opinions I have expressed are my own. I am disclosing this in accordance with the FTC Regulations.**

This e-book review was 137 pages in length and was very interesting to read at such a discounted rate on Amazon. The main theme to this book is can human life exist or survive without food? I think that the obvious answer to anyone would be clearly and immediately, no. This book shows a man named Ray Maor take on a path of utilizing air techniques to survive. Sounds pretty crazy, huh? I thought so too. In a television production, he went eight days without food and even water. He was never alone and always watched in a secure setting. Medical doctors and others feared he would not last. This e-book is about this journey of development but also so much more. A very interesting and different read! I loved the connection between the spiritual self and the body. I believe there is a real connection. The big hit of this book is the understanding of Chi and other defined terms of spiritual guidance. I would recommend this book to anyone that is spiritual or looking for interest in the connections of the body and mind. A+ read!

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[N315.Ebook] Get Free Ebook A Woman Soldier's Own Story: The Autobiography of Xie Bingying, by Xie Bingying

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This first English translation of Xie Bingying's entire autobiography (1906-2000) is the story of a rebellious child who became a soldier, a lover, a teacher-and a writer whose bravery and determination have inspired generations of readers. It provides a fascinating portrayal of a woman fighting to free herself from the constraints of ancient Chinese tradition amid the dramatic changes that shook China during the 1920s, '30s, and '40s.

• Sales Rank: #1395651 in Books
• Published on: 2003-02-25
• Released on: 2003-02-25
• Original language: English
• Number of items: 1
• Dimensions: 8.92" h x .67" w x 6.02" l,
• Binding: Paperback
• 304 pages

From Publishers Weekly
In lyrical, flowing prose, this absorbing autobiography interweaves politics, family relations and romance as it chronicles an extraordinary woman's struggle to free herself from traditional Chinese society. Born into a conventional family, Xie Bingying (1906-2000) was expected to be an obedient daughter and, later, daughter-in-law. A girl's education was largely restricted to learning how to spin cotton and embroider. Xie's reading was limited to such books as Teach Your Daughter Traditional Rules. Her fate was to be determined by her parents and a matchmaker. From an early age, Xie rebelled against these circumstances. Despite her mother's scolding, she dared to venture outside to play with the boys, and she fought fiercely against having her feet bound. In this chronicle of the first 32 years of her life, gracefully translated by her daughter and son-in-law, Xie recounts her efforts to secure an education, escape from an arranged marriage, raise an infant while a single mother and, chiefly, forge political change in China as a soldier in the National Revolutionary Army fighting the warlords who dominated much of China in the 1920s, and against the Japanese in the 1930s. Drawn to the bohemian life, Xie scoffed at financial and physical security, and gloried in her image as a "warrior who opposes all feudal rule," even when her choices summoned hunger, loneliness and imprisonment. The happiest day of her early life, she recalls, was the day in 1928 when her War Diary was published. She went on to become a noted author of novels, other autobiographical works and essays. This story of a Chinese feminist makes social and political issues of 20th-century China dramatically accessible to the lay reader. 12 photos, 3 maps.

Copyright 2001 Cahners Business Information, Inc.

From Library Journal
The efforts of women to emancipate themselves from restrictive social and family bonds is one of the central themes of modern Chinese history. A high degree of grit, intelligence, perseverance, and luck was required to succeed, particularly in the early decades of the 20th century. Xie Bingying had all those qualities in spades. Like a rocket escaping the pull of gravity, she hurtled from the remote village in central China where she was born in 1906 to a bohemian existence in urban China and eventually to a successful career as a teacher, essayist, novelist, and social activist. In 1927, she became a soldier in the Nationalist Army during its famous Northern Expedition. Her vivid and emotionally charged memoir, covering the first third of her life, was first published in China 60 years ago and is translated here by her daughter and son-in-law. An exemplar of the "new woman," Xie was an idealist and a romantic given to florid writing that matches the impressive melodrama of her life. For larger public and academic libraries. [Although sympathizing with the ideals of the Communist party, Xie Bingying was not a Communist and moved to Taiwan in 1948, becoming an ardent opponent of Mao. Ed.] Steven I. Levine, Univ. of Montana, Missoul.
- Steven I. Levine, Univ. of Montana, Missoula
Copyright 2001 Reed Business Information, Inc.

From Booklist
Born in 1906 in Xietuoshan, Xie Bingying demonstrated tenacity and decisiveness from a very early age despite the feudalistic Chinese society into which she was born. She was the daughter of a scholar and a traditional mother. Xie's feet were bound at the age of eight, and she was forced into an arranged marriage contract, but she would not allow any of these customs to tether her future. She sacrificed reputation, family, and love for the pursuit of books and literacy, and she threatened to kill herself if her needs were not met. Xie's unflinching character is demonstrated in her fearlessness as a soldier during Chiang Kai-shek's Northern Expedition and her zealous battle for truth and diplomacy in China. She was a tireless warrior on the front lines and a dedicated writer who endured poverty and endangered her life for propagation of the written word. As a potent feminist, she feared the vulnerability of love and its power to divert her from the path to enlightenment. Xie died in January of 2000 while her autobiography was being translated. Elsa Gaztambide
Copyright � American Library Association. All rights reserved

Most helpful customer reviews

1 of 1 people found the following review helpful.
I enjoyed her descriptions of people and places
By Amazon Customer
This is one of the most inspiring books I've read. Not only is Xie Bingying inspiring, but also the many selfless people whom she met and worked with. I enjoyed her descriptions of people and places. I compliment her family on their translation of her account; the book makes me feel as though I know Xie. It has also given me a much better feel for the Chinese people. Her account describes the magnitude and pain of the people's struggle against oppressive traditions, and mixed into this simultaneously are the fights against invaders and the infighting of the Chinese revolutionary and political movements. The period seems almost to have been all the world's history wrapped up into a single generation in China.

0 of 0 people found the following review helpful.
Five Stars
By Cantalicio
Good textbook

0 of 1 people found the following review helpful.
Not a bad read.
By Chris Sitko
Had to read it for Asian Civilization class. Not a bad read.

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[Z291.Ebook] Fee Download Halt Station India: The Dramatic Tale of the Nation's First Rail Lines, by Rajendra B. Aklekar

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Halt Station India chronicles the dramatic rise of India's original rail network, the arrival of the first train, and the subsequent emergence of a pioneering electric line-all in the port city of Bombay. Trains that once provoked awe and fear-they were viewed as fire chariots, smoke-spewing demons-have today become a nation's lifeblood. Taking a walk along India's first rail lines, the author stumbles upon fragments of the past-a clock at Victoria Terminus that offers a rare view of a city; a cannon near Masjid Bunder Station that is worshipped as a god; a watchtower overlooking Sion Station, believed to have housed a witch. Each pit-stop comes with stories of desire and war, ambition and death-by Dockyard Road Station, for instance, author Laurence Sterne's beloved, Eliza Draper, followed a sailor into the sea; or close to Parel Station, the wife of India's governor general, Lord Canning found a garden rich in tropical vegetation; this, she replicated at Barrackpore. Drawing from journals, biographies, newspapers and railway archives-and with nostalgic, first-time accounts of those who travelled by India's earliest trains-the book captures the economic and social revolutions spurred by the country's first train line. In this, Halt Station India is not just about the railways-it is the story of the growth of India's business capital and a rare study of a nation.

• Sales Rank: #1362121 in Books
• Published on: 2014-12-01
• Released on: 2015-01-07
• Original language: English
• Dimensions: 8.50" h x .58" w x 5.50" l, .57 pounds
• Binding: Paperback
• 227 pages

Review
Rajendra B. Aklekar s research and his scholarship which enables him to interpret his findings throws new light on the way railways were built. --Sir Mark Tully, author of Non-Stop India

Fascinating stuff. An enormous amount of really rigorous work. --Naresh Fernandes, author of City Adrift: A Short Biography of Bombay

About the Author
A journalist for the past twenty years, Rajendra B. Aklekar has two things on his mind the railways and Bombay. He started his career with Rusi Karanjia s firebrand The Daily, where he used to run a weekly column on the history of Bombay s railway stations. Presently, Aklekar is associated with The Times Group s Mumbai Mirror. He has trained himself in museology to document Bombay s vanishing relics, helped the railways set up heritage galleries, and worked on several prestigious projects to conserve the city s ancient structures.

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[D751.Ebook] Get Free Ebook Persuasion in The Media Age with PowerWeb, by Timothy Borchers

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By providing an accessible account of theoretical information, this text enables students to explore and understand the role of persuasion in the world today. Although the text is grounded in rhetorical theory, social science research is interwoven throughout to provide a comprehensive account of persuasion. The new edition features enhanced Web pedagogy with Internet-based activities for each chapter, updated examples, and updated discussion of theory, including new theories such as Problematic Integration Theory.

• Sales Rank: #1314279 in Books
• Published on: 2004-04-23
• Original language: English
• Number of items: 1
• Dimensions: 8.60" h x .88" w x 8.30" l,
• Binding: Paperback
• 448 pages

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1 of 1 people found the following review helpful.
Great Book
By Katielee
I bought this book for my theories of Persuassion Class. Although I found out that you really do not use the book all that often in the class, the material was still relevent to the class and even helped you understand and comprehend theories that perhaps your Romanian teacher couldnt explain quite as well herself.

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[X275.Ebook] Fee Download An American Tragedy, by Theodore Dreiser

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An American Tragedy

• Sales Rank: #1530756 in Books
• Published on: 1953
• Number of items: 2
• Binding: Hardcover

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188 of 204 people found the following review helpful.
Long but Worthy
By Jeffrey Leach
Theodore Dreiser (1871-1945) is one of the giants of American letters. His novel "Sister Carrie," written in 1900, is a cathedral of naturalist literature. Almost as epic as his novels was the constant state of warfare that existed between Dreiser and publishers who consistently refused to publish his books because of the shocking themes the author wrote about. One of his biggest battles involved "An American Tragedy," a sprawling book based on a real murder case that occurred in New York at the beginning of the 20th century. Dreiser used the Chester Gillette/Grace Brown episode as the basis for a story that strongly criticized America's infatuation with materialism and social status. In the Gillette case, a young dandy with an eye for the ladies impregnated a young woman and then drowned her in a lake when her condition threatened to put an end to his social life. During the subsequent trial of Chester Gillette, all of America readily soaked up the sordid details of the case. Gillette, vehemently denying that he had anything to do with Grace Brown's murder despite his conviction on a first-degree murder charge, died in the electric chair at Auburn State Prison on March 30, 1908. Dreiser went to such lengths investigating the case for his book that he even took his wife out on the lake where Gillette committed his crime, apparently worrying his spouse that he might recreate the crime.
In "An American Tragedy," Chester Gillette becomes Clyde Griffiths, the son of itinerant evangelists who roam the country operating missions for the destitute. His parents often take Clyde and his siblings out on the streets of the city in order to sing hymns and hand out religious tracts. While in Kansas City, Clyde reaches the age of sixteen and decides to strike out on his own. Tired of the austere life led by his family, Clyde secures a job as a bellboy at a big hotel downtown. The money he earns and the friends he makes at the hotel quickly lead to Clyde's indoctrination into the fast life of fine clothes, fine food, and fast women. An unfortunate incident with a "borrowed" car leads to his hasty departure from Kansas City to points east.
After a few years of drifting from job to job under an assumed name, Clyde happens to run into a rich uncle at a hotel in Chicago. The uncle, moderately impressed with his nephew's appearance and attitude, offers the young man a job at his collar factory in Lycurgus, New York. Clyde jumps at the opportunity, picturing himself rising quickly at the factory into a world of wealth and privilege. The reality turns out to be quite the opposite. His uncle is indifferent to Clyde's presence, rarely inviting him out to the family estate and starting him at the lowest, dirtiest job in the factory. A cousin named Gilbert also proves troublesome to Clyde's aspirations. Gilbert sees his poor cousin as a real threat to his own position as heir apparent at the factory. Moreover, Gilbert and Clyde are astonishingly similar in appearance. Despite these obstacles, Clyde is optimistic that he will win over his cousin and uncle after a few months time. But he needs to move fast when he meets Sondra Finchley, the daughter of one of the richest families in Lycurgus. If only Clyde could woo this pretty girl and get a good position at the factory! All his dreams would come true!
Clyde's dreams nearly do reach fruition until he finds himself in a spectacularly scandalous position. For when Sondra finally decides to make a move for Clyde, she doesn't know about his involvement with a poor factory girl named Roberta Alden. The inevitable eventually happens: Clyde impregnates Roberta at a time when Sondra professes her love for him. Griffiths is in a real pickle now, for he must drop Roberta so he can position himself with Sondra. Clyde convinces Roberta to seek a way out of the pregnancy but various methods fail to work. All seems disaster until Clyde remembers an article in the paper about a drowning at a local lake, and an unthinkable plan begins to form.
The minute detail of Clyde's rise and eventual fall leaves no stone unturned. The chapters covering the defense and prosecution's questioning of Clyde during his murder trial cover some seventy pages. Sometimes the details are too much, such as a description of a car accident that takes up way too many pages. Dreiser's mania for detail may be the biggest failing of "An American Tragedy" because the reader quickly becomes impatient with the pace of the story as the narrative bogs down under a mass of minutiae. Moreover, the author's convoluted prose style leaves a lot to be desired. His language is often so dense that even H.L. Mencken commented on it in the introduction to the story.
BUT, and this is a big but, Dreiser's story is deeply affecting. It is well worth reading 850 pages to experience the mind blasting intensity of the story. This is truly a tragedy, as Clyde's crime ruins dozens of people's lives. And such a powerful conclusion! Clyde's march to the electric chair brought tears to my eyes, especially when his mother chucks all the religious chatter, grabs her son, and murmurs "my son, my baby." Then note how Dreiser brings the story full circle after the execution. That is what the author does with this story: he makes you feel for nearly every character in the narrative. Ultimately, "An American Tragedy" is a great book with a few niggling problems. You will be glad you read it, though.

49 of 50 people found the following review helpful.
STOP! Don't read any summaries, just read the book.
By Roman
I chose this book simply because it was on Modern Library's 100 Greatest books of the 20th century list. I knew nothing about the author and from the title and the summary on the back, knew only that probably something bad would happen. This is the way to read the book.

People have said that it is overly long or wordy. It may seem like this in the beginning, but even at this part the book is not boring or dry. It is the story of a boy growing and maturing at this point, and it is precisely this personal growth (in detail) that makes the book so powerful. You, as the reader, become one with the protagonist because you have witnessed his entire life.

The preface in the version I read said something to the effect that the story builds slowly like a tsunami, finally striking you with all that built-up force. I am a 29 year old male who does not often cry, and I was in tears for the last hour of this book. After finishing I looked at myself in the mirror and I was shaking and my eyes were completely bloodshot. My only thought was what a terrible book that was, and why anyone would write something like this.

I read a lot of the supposed "best books" like the ones on the Modern Library list, and this is the most immediately powerful novel I have ever read.

65 of 70 people found the following review helpful.
A Simple Plan
By brewster22
The film "A Simple Plan" could have easily been called "An American Tragedy," and the book "An American Tragedy" could have just as easily been called "A Simple Plan." The plan at the book's center seems so simple indeed. The novel's protagonist, Clyde Griffiths, impregnates a girl below his social station, and he's so terrified by the idea of being exposed and ruining his chances at a life as part of the social elite (and losing the local well-to-do beauty to whom he's hitched himself) that he actually finds himself driven to kill her as his only escape. But Clyde has a simple mind, and his efforts to claw his way out of a desperate situation that inexorably suffocates him is compelling fiction.
Theodore Dreiser has been called one of the worst great writers in the history of literature, and that claim is justified. He can hardly compose a sentence that doesn't drop like lead from the tongue. He's especially fond of the double negative, which can become pretty tedious in a 900+ page novel. And in retrospect, the amount of plot on display in his novel does not seem to warrant its length, but somehow, I was able to overcome these two factors and find myself engrossed in it anyway. It doesn't for one second become boring or slow. And it offers some especially candid and frank ideas about the nature of guilt and the culpability of those who take lives, whether they're working on the side of crime or the law. Most fascinating for me were the novel's final pages, when Clyde tries to turn to religion for solace when he's at his loneliest, but can't get around the notion that there's really nothing to turn to.
Dreiser pulls off quite a feat by making all of his characters sympathetic. I didn't want Clyde to get away scot-free with what he'd done, but my heart couldn't help but go out to him. Likewise, Roberta, the girl he wrongs, could have come across as shrewish in another author's hands (she does in the film version, "A Place in the Sun," if you're interested in a literature to film comparison) but she doesn't here. Even Sondra, who could have been so unlikeably spoiled, comes across as essentially a warm character.
1925 was the literary year for deconstructing the American Dream. Both "An American Tragedy" and "The Great Gatsby" came out that year, and while I have to admit that "Gatsby" is a better written book, "Tragedy" just has a visceral appeal for me, and it's the one I enjoyed more.

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Medical Device Development: Regulation and Law, 2014 Edition, is the ''must-have'' resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. Since the 2009 edition of this book, new device legislation has been enacted and FDA has issued over a dozen or more important new guidances. The 2014 edition features in-depth analysis of these developments, and addresses how emerging developments and trends are reshaping medical device and combination product regulations in the US. The 2014 edition of this popular and authoritative resource reviews and analyzes the following critical developments since the 2009 edition: * Update on all the new provisions of the Food and Drug Administration Safety and Improvement Act of 2012 (FDASIA). * New statutory provisions and guidances related to device reclassification, humanitarian devices, the CDRH appeal process, Section 522 postmarket surveillance, and custom devices. * New statutory provisions and guidances related to mobile medical apps and medical device software, including medical data software systems. * Updates on the new organizational structure of CDRH, including revisions to the structure of the Office of Device Evaluation the Office of Compliance, and the Office of In Vitro Diagnostics and Radiological Health. * Changes to the 510(k) premarket notification process, including new policies on split predicates, when a device cannot be found to be SE, and the new priority review guidance. * Changes to the pre-submission process, including the end of the pre-IDE process and the birth of the Q-sub. * New guidances on FDA s Refusal to Accept policies relating to 510(k)s, PMA s, and pre-submissions. * Update on the investigational device exemption process, including new guidances on early feasibility studies, FDA decisions for IDE investigations, design considerations for pivotal clinical device investigations, and good laboratory practices. * Changes to the premarket approval application process, including birth of the e-copy and modifications to the advisory panel process. * New policies and guidances concerning in vitro diagnostic products, including the new guidances on Research Use Only (RUO)/Investigational Use Only (IUO) products, and in vitro companion diagnostics. * Update on device compliance issues, including the 2013 draft medical device reporting guidance and recall procedures relating to product enhancements. * New guidances and cases relating to combination products incorporating medical devices.

• Sales Rank: #61011 in Books
• Published on: 2014-03-01
• Binding: Hardcover
• 622 pages

Review
Great book for a beginner learning about process, or an experienced practitioner in the field. I used prior addition, until i realized it was updated - i testify on matters of value in the field of medical devices, and nothing helps the court understand faster - than a text book you can cite documenting the process of a 510(k) application or a PMA! --Richard Mackenzie, Amazon Verified Purchase

I recently acquired a copy of Jonathan Kahan s book entitled Medical Device Development: Regulation and Law, in its most recent edition. I have been in the regulatory affairs profession for over 23 years now, and can easily navigate websites and references to find the information I need. However, as I was reviewing a recent FDA proposed rule, I found myself repeatedly reaching out to the book as all the information I needed was compiled and easily found in one place, organized by topic, with all needed legislative and regulatory references. Mr. Kahan has done an admirable job in creating this book, and I am thankful to have it on my desk for easy reference when needed. --Tamima Itani, Ph.D., FRAPS, RAC MSVP, Global Regulatory Affairs and Regulatory Compliance, Boston Scientific

About the Author
The book is written by Jonathan S. Kahan, Partner, Hogan Lovells US LLP in Washington, D.C. Jon is a co-director of the firm s food, drug, medical device, and agriculture group, and has been practicing in FDA law for 40 years. Jon is also an Adjunct Professor at the George Washington University Law School teaching medical device law. His practice focuses primarily on assisting medical device companies in navigating the U.S. Food and Drug Administration (FDA) regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices, and biologics. In addition to the daily counseling of clients in FDA-related matters, he represents many clients in administrative hearings and trials, and in the federal courts. Jon has published numerous law review and other articles concerning FDA regulatory issues.

Most helpful customer reviews

2 of 2 people found the following review helpful.
Excellent, readable resource
By Susan Cook
Thorough review of the latest regulations, practices and thinking by the FDA. The book indicates the areas where there is still ongoing debate and lets the reader know the regulation at the time of printing, then provides information for finding if there are new updates since the printing. I like that the book is not fully pro FDA - it objectively discusses FDA actions and history of the evolution of the current regulations. I was not looking forward to having to read this book for a Medical Device class, but now have found it interesting and even engrossing to read. This is one of those books that I will use as a go-to guide for anything related to medical device regulation.

0 of 0 people found the following review helpful.
Comprehensive resource
By D. Coral
Many changes have occurred since the 2009 edition. This latest update keeps on top of these recent changes including "guidances related to mobile medical apps and medical device software, including medical data software systems" driven by all the new technology (e.g. iPads). It is very interesting reading as well. This is a must-have on your shelf if you are involved in any aspect of medical device regulation.

0 of 0 people found the following review helpful.
Good reference, simplifies and summarizes FDA.gov information on Medical Devices
By Tate
Good book for references especially if you are new to the medical device industry, need a refresher, and/or if you need the FDA website simplified and summarized for you.

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• Sales Rank: #873649 in Books
• Brand: Brand: Cambridge University Press
• Published on: 2008-01-14
• Released on: 2007-12-13
• Original language: English
• Number of items: 1
• Dimensions: 9.72" h x .67" w x 6.85" l, 1.25 pounds
• Binding: Paperback
• 314 pages

Features

• Used Book in Good Condition

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• Published on: 1600
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