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Summary Of The Purple Book

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Keyword:, Purple book The US Food and Drug Administration (FDA) published the first edition of the Purple Book on September 9, 2014. It is formally known as the Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. It was published several years after the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010. The primary purpose of the book is to provide information about whether or not licensed biological products are categorized as biosimilar or interchangeable with a reference biological product by the FDA. It also contains details about existing reference product exclusivity, which protects a reference biological project. Although FDA was not required under BPCIA to publish a list of licensed biological products, the same way the Hatch-Waxman Amendments did, the agency took the initiative to provide a reference guide to anyone who will find it useful. …show more content…

According to the FDA, it is a nickname that is easy to remember. It also draws upon the agency’s long-held practice of using colors as nickname. The Approved Drug Products with Therapeutic Equivalence Evaluations, for example, is nicknamed as the Orange Book. What are the two sections of the book? The Lists of Licensed Biological Products is a compilation of lists organized by the FDA Center: Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). So each section is labeled as: (1) Center for Biologics Evaluation and Research (“CBER”) List of Licensed Biological Products (2) Center for Drug Evaluation and Research (“CDER”) List of Licensed Biological Products What exactly is its content? • Each listing include the following information: • Biologic license application (BLA) number • Nonproprietary product name • Brand

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The Orphan Drug Act of 1983 was signed for the main purpose of promoting the research, treatment, prevention and diagnosis of rare disease or condition. Here the products which are used in rare disease can be drugs, biologics and medical devices. A rare disease means any disease which affects less than 200,000 persons in the United States or one in which the manufacturer has no expectation of recovering the money from development and sales in the United States. According to this act, there are certain incentives will be provided to the manufacturers who will develop orphan drug for the rare disease and condition. Thus, this act can encourage the treatment for rare disease.

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FDA’s responsibilities accumulated over time in a way that it firstly extended control to cosmetics and therapeutics devices under The Federal Food, Drug, and Cosmetic (FDC) Act of 1938. Also it has several amendments in the following decades covering additives, pesticides, animal drugs and so on. Later on, it has responsibilities in nutrition, drugs export, medical devices, supplements, health and education

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West Encyclopedia (2005) studies show that “The FDA annually regulates over $1 trillion worth of products, which accounts for one-fourth of all consumer spending in the United States.” The FDA protect patients’ rights and safety in clinical trials of new medical products, monitor promotional activities and regulate labeling of packaged foods. The FDA is responsible for monitoring the safety of the nation’s blood supply.

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How well can a director put a book into action as a movie? After reading the book The Color Purple by Alice Walker and watching the movie The Color Purple directed by Steven Spielberg, I was given both sides of the story written and the screen write. Contrasting the two together personally is quite tricky because both the book and the movie were great to take part in. However some events in the book were obviously different when watching the movie.

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Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property 1. Ethical Issues Related to Marketing and Advertising, Intellectual Property, and Regulation of Product Safety The principle of due care to consumers holds that pharmaceutical companies have the responsibility to make drugs that are safe for the patients (Boatrigh, 2006). A drug is deemed as safe if its related risks are known to and ruled by the consumers as acceptable and reasonable in view of the benefits they expect to receive from using it. Drug manufacturers, on the other hand, must comply with their part of the free agreement by manufacturing products whose risks are no greater than those expressly communicated to the consumers.

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Darren Driscoll Mrs. Richardson Diverse Voices (D) March 27, 2018 The Color Purple Sacatic 1. In The Color Purple, women are portrayed as lesser to men in the book. Examine how the reason of women being portrayed as beneath men is because of their gender or because of their ethnicity.

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The Purple Children - Response by Sarah Azoulay One of the main ideas of this short story is man’s need for freedom. The presence of military officials indicates a lack of freedom amongst the Natives. We can see proof of this as there is a curfew and restricted areas, such as the cemetery.

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Alice Malsenior Walker is an American novelist, short story writer, poet, activist, and womanist. She was born to a farmer and a maid, who were sharecroppers in Eatonton, Georgia (Putnam County), February 9, 1944. She wrote the novel The Color Purple, for which she won the National Book Award for hardcover fiction and the Pulitzer Prize for Fiction. Next, the people who inspired Alice Walker were Hurston, Harlem Renaissance writer Jean Toomer, black Chicago poet Gwendolyn Brooks, South African novelist Bessie Head, and white Georgia writer Flannery O'Connor. She went to Sarah Lawrence College in 1965 and Spelman College in 1961.

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The three women I have decided to write about are the women who are not recognized enough for their actions. Their names have been lost behind their works or overshadowed by white-washed America. The first female African American Feminist I would like to right about is Alice Walker. Walker is a writer who was very active during the civil-rights movement. She protested and fought for not only women, but people of color.

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The Color Purple Julie Bennett Rasmussen College This paper is being submitted on June 16th, 2015, for Deborah Jepson’s ESUM15-6WS2-G435-01 Literature of American Minorities This novel focuses on the growth and development of a girl named Celie. Raped at 14 by her father and then forced into a marriage with a cold-hearted older man, Celie learns to be silent and obedient. “Well how you suspect to make her mind?

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“All my life I had to fight. I had to fight my daddy. I had to fight my uncles. I had to fight my brothers. A girl child ain't safe in a family of men, but I ain't never thought I'd have to fight in my own house!”

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Alice Walker, a poet and activist once said that “a womanist is to feminist as purple is to lavender.” Womanism is just another shade of feminism. It helps give awareness to the experience of black women and other women of color who have always been at the forefront of the feminist movement, but made invisible in historical texts and the media. Although feminism addresses and fights for gender equality, it rarely addressed equality and justice for black women in the civil rights movement. On the other hand, womanism not only fights for the gender equality but for justice against racial oppression against African American men and women.

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PORTERS FIVE FORCES ANALYSIS - PHARMA INDUSTRY Using Porter's Five Forces we can analyse the scope of the pharmaceutical industry. It looks into five factors namely, competitive rivalry, threat of new entrants, threat of substitute products, bargaining power of suppliers and bargaining power of customers. " Competitive rivalry: The pharmaceutical industry is highly fragmented with almost 3,000 pharma companies and 10,500 manufacturing units. Due to increasing demand of high-quality drugs, low-to-moderate entry barrier to the new entrant, the presence of a number of large and small firm this market is highly competitive.

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A moving inspirational novel told in letters to portray how life was for African Americans, and especially women is The Color Purple. It is not about purple in no way at all; it is actually a difficult book to tackle, dealing with rape insest, explicit sex, sexism, and violence toward women and a lesbian relationship. Not only does it speak of women, but it tells of how there was a negative depiction of African American men during this time. The novel consists of letters written by the main protagonist, Celie, that she has written to God.

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The Color Purple was published in 1982, written by Alice Walker. Alice grew up and lived in Eatonton, Georgia and worked as a social worker, teacher, lecturer, and took part in the 1960’s Civil Rights Movement in Mississippi. Alice decided to write this novel to describe the struggles of three generations of Georgia sharecroppers. This novel sold more than 5 million copies and won the Pulitzer Prize for fiction in 1983. (“Alice Walker”)

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