Law and Law Reference
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
2nd Edition Hardcover ISBN: 0873897404
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485:2003 standard and the ISO/TR 14969:2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes and update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs. Annotation ©2008 Book News, Inc., Portland, OR (booknews.com)
No Matter How Loud I Shout
A Year in the Life of Juvenile Court
Hardcover ISBN: 0684811944
A journalist's profile of a juvenile court and its judges, lawyers, probation officers, and children focuses on five specific troubled minors and reveals the system's impact on their lives and their prospects. 25,000 first printing.
Last Man Standing
The Tragedy and Triumph of Geronimo Pratt
Paperback ISBN: 0385493681
Describes the twenty-seven-year battle to vindicate Elmer Gerard "Geronimo" Pratt, a Vietnam veteran and Black Panther Party leader convicted in a trumped-up case of murder, in an intriguing study of government conspiracy and judicial abuse. Reprint. 30,000 first printing.
Plain English for Lawyers
4th Edition Paperback ISBN: 0890899940
Carolina Academic Press will publish the fifth edition of Richard Wydick’s Plain English for Lawyers in time for use in the fall of 2005. Wydick’s little book has been a favorite of law students, legal writing teachers, lawyers, and judges for over 25 years.Last January, the Legal Writing Institute gave Wydick its Golden Pen Award for having written Plain English for Lawyers. The Legal Writing Institute is a non-profit organization that provides a forum for discussion and scholarship about legal writing, analysis, and research. The Institute has over 1,300 members representing all of the ABA-accredited law schools in the United States. Its membership also includes law teachers from other nations, English teachers, and practicing lawyers.The LWI award states: “Plain English for Lawyers . . . has become a classic. Perhaps no single work has done more to improve the writing of lawyers and law students and to promote the modern trend toward a clear, plain style of legal writing.
Gay Marriage: for Better or for Worse?
What We've Learned from the Evidence
Hardcover ISBN: 0195187512
Opponents of same-sex marriage in the United States often claim that allowing gays and lesbians to marry will lead to the downfall of the institution of marriage and will harm children. Drawing from 16 years of data and experience with same-sex unions in Scandinavia, Gay Marriage: For Better or for Worse? is the first book to present empirical evidence about the results of same-sex marriage (in the form of registered partnerships) from the Nordic countries. Spedale and Eskridge demonstrate that conservative defense-of-marriage arguments that predict negative effects from gay marriage are invalid, and the Scandinavian experience suggests that the institution of marriage may indeed benefit from the enactment of gay marriage. If we look at the proof from abroad, the authors argue, we must conclude that the sanctioning of gay marriage in the United States would neither undermine marriage as an institution, nor harm the wellbeing of our nation's children.
Oxford Companion to the Supreme Court
Hardcover ISBN: 0195058356
A compendium of information on this seminal American institution includes a thousand entries covering the people, cases, and issues that have dominated the Court over the past two hundred years. 20,000 first printing. $20,000 ad/promo.