Roswell: the Ultimate Cold Case

by Thomas J. Carey, Donald R. Schmitt

2020 · New Page Books

"For more than 70 years, the crash at Roswell and its ensuing controversies and cover-ups have been investigated; yet despite continually mounting evidence, there are still disbelievers. This book is the final and commanding word on the case. The government has changed their official story on Roswell more than a dozen times, but the witnesses have not recanted. The evidence has not gone away. And won't go away. The Roswell Incident is the most hotly debated and investigated UFO crash in history and has had a seemingly never-ending amount of evidence, eyewitnesses coming forward even years later. Finally, late in life, people feel safe enough or duty bound to reveal what they know, saw, and heard"--

The Legal Foundations of Public Administration

by Donald D. Barry, Howard R. Whitcomb

2005 · Bloomsbury Publishing PLC

The third edition of this highly respected textbook introduces students of public administration to the practical issues of administrative law. While useful to law school students, it is most relevant to public management students. The presentation provides a concise foundation to the history and theory of administrative law, rule making, and judicial decisions. The most important issues in administrative law are included--meaningful issues for present and future administrators. A larger number of recent cases and other up-to-date information will be found in the book in order to make the student aware of the kinds of legal problems likely to be encountered in public agencies. One or two cases illustrate each problem at hand, rather than discussing numerous arcane court decisions and technicalities of legal procedure, in order to sketch the broad contours of the present law.

Generic and Innovator Drugs

by Donald O. Beers, Kurt R. Karst

2013 · Wolters Kluwer

Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.

Marine Products of Commerce

by Donald Kiteley Tressler, Ward Taft Bower

1923

Excerpt from preface: This book is designed for both the scientific and the practical man. It attempts to give the chemist and biologist a general survey of the fishery industries, pointing out their relative importance, indicating their location, and describing the methods in common use. There has been no attempt to consider all the methods of the fisheries; if this were attempted, a lengthy treatise such as G. Brown Goode's "Fisheries and fishery industries of the United States" would result. By reading this book, the practical man may learn how chemistry and biology are correlated with the fishery industries. Simple language is used throughout. But few technical terms are included and care is taken to define those terms which may not be familiar to the layman. The author hopes that this book may fill the long felt need of the student of industrial biology, for a concise treatise on the fishery industries. These industries have been considered from a scientific viewpoint and, while it is impossible to go into great detail in describing the applications of chemistry, physics, and biology in the preparation and preservation of marine products, the applications are outlined and references to the original literature are given which should serve as a guide for study. In all cases, special consideration is given to American methods and processes. Obviously, it is impossible to treat of the technology of the marine products industries in all parts of the world; however, especially important foreign industries are described. A special effort is made to describe carefully the manufacture and refining of solar sea salt. It is hoped that the information presented will be of value not only to the student of industrial chemistry and the marine industries but also to the salt manufacturer. It is hoped that the book may call attention to the great need for chemical and biological research to solve the numerous problems of the fishery industries. Several of these problems are brought to the attention of the reader in the last chapter.