Susan Thaul's Books

The Five Series Study

Mortality of Military Participants in U.S. Nuclear Weapons Tests

By: Institute of Medicine,Medical Follow-up Agency,Committee to Study the Mortality of Military Personnel Present at Atmospheric Tests of Nuclear Weapons,Heather O'Maonaigh,Harriet Crawford,William F. Page,Susan Thaul

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The Five Series Study

Mortality of Military Participants in U.S. Nuclear Weapons Tests

More than 200,000 U.S. military personnel participated in atmospheric nuclear weapons tests between 1945 and the 1963 Limited Nuclear Test Ban Treaty. Questions persist, such as whether that test participation is associated with the timing and causes of death among those individuals. This is the report of a mortality study of the approximately 70,000 soldiers, sailors, and airmen who participated in at least one of five selected U.S. nuclear weapons test series1 in the 1950s and nearly 65,000 comparable nonparticipants, the referents. The investigation described in this report, based on more than 5 million person-years of mortality follow-up, represents one of the largest cohort studies of military veterans ever conducted.

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239

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National Academies Press

Published Date

ISBN 10

0309172594

ISBN 13

9780309172592

The Five Series Study

Mortality of Military Participants in U.S. Nuclear Weapons Tests

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The Five Series Study

Mortality of Military Participants in U.S. Nuclear Weapons Tests

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239

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National Academies Press

Published Date

ISBN 10

0309067812

ISBN 13

9780309067812

FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

By: Susan Thaul

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FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

By: Susan Thaul

On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since November 10, 2011.) With the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), Congress authorized the Food and Drug Administration (FDA) to offer drug manufacturers financial and regulatory incentives to test their products for use in children. Congress extended both programs with the FDA Amendments of 2007 (FDAAA) and, because of the programs' sunset date, must act before October 1, 2012, to continue them. This report presents the historical development of BPCA and PREA, their rationale and effect, and FDAAA's impact. The report also discusses pediatric drug issues that remain of concern to some in Congress. Most prescription drugs have never been the subject of studies specifically designed to test their effects on children. In these circumstances, clinicians, therefore, may prescribe drugs for children that FDA has approved only for adult use; this practice is known as off-label prescribing. Although some clinicians may believe that the safety and effectiveness demonstrated with adults would hold for younger patients, studies show that the bioavailability of drugs—that is, how much gets into a patient's system and is available for use—varies in children for reasons that include a child's maturation and organ development and other factors. The result of such off-label prescribing may be that some children receive ineffective drugs or too much or too little of potentially useful drugs; or that there may be side effects unique to children, including effects on growth and development. Drug manufacturers are reluctant to test drugs in children because of economic, ethical, legal, and other obstacles. Market forces alone have not provided manufacturers with sufficient incentives to overcome these obstacles. BPCA and PREA represent attempts by Congress to address the need for pediatric testing. FDA had tried unsuccessfully to spur pediatric drug research through administrative action before 1997. With the FDA Modernization Act of 1997 (FDAMA, P.L. 105-115), Congress provided an incentive: if a manufacturer completed pediatric studies that FDA requested, the agency would extend the company's market exclusivity for that product for six months, not approving the sale of another manufacturer's product during that period. In 2002, BPCA (P.L. 107-109) reauthorized this program for five years. In 1998, to obtain pediatric use information on the drugs that manufacturers were not studying, FDA published the Pediatric Rule, which required manufacturers to submit pediatric testing data at the time of all new drug applications.

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Createspace Independent Pub

Published Date

ISBN 10

1478201673

ISBN 13

9781478201670

An Assessment of the NIH Women's Health Initiative

By: Institute of Medicine,Committee to Review the NIH Women's Health Initiative

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An Assessment of the NIH Women's Health Initiative

By: Institute of Medicine,Committee to Review the NIH Women's Health Initiative

The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fracturesâ€"leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.

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159

Publisher

National Academies Press

Published Date

ISBN 10

030904989X

ISBN 13

9780309049894

Potential Radiation Exposure in Military Operations

Protecting the Soldier Before, During, and After

By: Institute of Medicine,Committee on Battlefield Radiation Exposure Criteria

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Potential Radiation Exposure in Military Operations

Protecting the Soldier Before, During, and After

By: Institute of Medicine,Committee on Battlefield Radiation Exposure Criteria

In 1996, NATO issued guidance for the exposure of military personnel to radiation doses different from occupational dose levels, but not high enough to cause acute health effects-and in doing so set policy in a new arena. Scientific and technological developments now permit small groups or individuals to use, or threaten to use, destructive devices (nuclear, biological, chemical, and cyber-based weaponry, among others) targeted anywhere in the world. Political developments, such as the loss of political balance once afforded by competing superpowers, have increased the focus on regional and subregional disputes. What doctrine should guide decisionmaking regarding the potential exposure of troops to radiation in this changed theater of military operations? In 1995, the Office of the U.S. Army Surgeon General asked the Medical Follow-up Agency of the Institute of Medicine to provide advice. This report is the final product of the Committee on Battlefield Radiation Exposure Criteria convened for that purpose. In its 1997 interim report, Evaluation of Radiation Exposure Guidance for Military Operations, the committee addressed the technical aspects of the NATO directive. In this final report, the committee reiterates that discussion and places it in an ethical context.

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Page Count

160

Publisher

National Academies Press

Published Date

ISBN 10

0309064392

ISBN 13

9780309064392

The Five Series Study

Mortality of Military Participants in U.S. Nuclear Weapons Tests

By: Susan Thaul,William F. Page,Harriet Crawford

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The Five Series Study

Mortality of Military Participants in U.S. Nuclear Weapons Tests

By: Susan Thaul,William F. Page,Harriet Crawford

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199

Publisher

National Academies Press

Published Date

ISBN 10

0309073642

ISBN 13

9780309073646

FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe

By: Susan Thaul

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FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe

By: Susan Thaul

The Food and Drug Admin. (FDA) has approved for adult use many drugs that have been tested for adults but not for children. Yet clinicians often prescribe adult-approved drugs for children, a practice known as off-label prescribing, (1) because most drugs have not been tested in children, and (2) because clinicians presume that the safety and effectiveness demonstrated with adults generally means that the drugs are also safe and effective for children. However, research shows that this is not always true. Children may need higher or lower doses than adults, may experience effects on their growth and development, and may not respond to drugs approved for adults. Contents of this report: Understanding Drug Effects in Children; Why Manufacturers Have Not Tested Most Drugs in Children; Laws to Encourage Pediatric Drug Research; Issues for Reauthorization of These Laws; Concluding Comments. Tables. This is a print on demand report.

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ISBN 10

1457836319

ISBN 13

9781457836312

LETTERS OF SUSAN HALE

By: Susan 1833-1910 Hale

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LETTERS OF SUSAN HALE

By: Susan 1833-1910 Hale

This work has been selected by scholars as being culturally important, and is part of the knowledge base of civilization as we know it. This work was reproduced from the original artifact, and remains as true to the original work as possible. Therefore, you will see the original copyright references, library stamps (as most of these works have been housed in our most important libraries around the world), and other notations in the work. This work is in the public domain in the United States of America, and possibly other nations. Within the United States, you may freely copy and distribute this work, as no entity (individual or corporate) has a copyright on the body of the work. As a reproduction of a historical artifact, this work may contain missing or blurred pages, poor pictures, errant marks, etc. Scholars believe, and we concur, that this work is important enough to be preserved, reproduced, and made generally available to the public. We appreciate your support of the preservation process, and thank you for being an important part of keeping this knowledge alive and relevant.

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Page Count

530

Publisher

Wentworth Press

Published Date

ISBN 10

1371677921

ISBN 13

9781371677923

An Account of the Proceedings on the Trial of Susan B. Anthony

By: Susan Brownell Anthony

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An Account of the Proceedings on the Trial of Susan B. Anthony

By: Susan Brownell Anthony

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222

Publisher

Wentworth Press

Published Date

ISBN 10

0526167602

ISBN 13

9780526167609

Where Are My Susannas

By: Susan Hyatt

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Where Are My Susannas

By: Susan Hyatt

Discusses Susanna Wesley, Phoebe Palmer, and Aimee Semple McPherson.

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Liturgy Training Publications

Published Date

ISBN 10

1888435038

ISBN 13

9781888435030

Book's by Susan Thaul

The Five Series Study

The Five Series Study

The Five Series Study

The Five Series Study

FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

An Assessment of the NIH Women's Health Initiative

An Assessment of the NIH Women's Health Initiative

Potential Radiation Exposure in Military Operations

Potential Radiation Exposure in Military Operations

The Five Series Study

The Five Series Study

FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe

FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe

LETTERS OF SUSAN HALE

LETTERS OF SUSAN HALE

An Account of the Proceedings on the Trial of Susan B. Anthony

An Account of the Proceedings on the Trial of Susan B. Anthony

Where Are My Susannas

Where Are My Susannas

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