Marcia Crosse's Books

Ryan White Care Act

Factors That Impact HIV and AIDS Funding and Client Coverage

By: Marcia Crosse (au)

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Ryan White Care Act

Factors That Impact HIV and AIDS Funding and Client Coverage

By: Marcia Crosse (au)

The Ryan White Comprehensive AIDS Resources Emergency Act (CARE Act) was enacted in 1990 to respond to the needs of individuals & families living with AIDS. In FY 2004, over $2 billion in funding was provided through the CARE Act, the majority of which was distributed through Title I grants to eligible metro. areas & Title II grants to states & territories. Here are findings on: the impact of CARE Act prov. that dist. funds based on the no. of AIDS cases in metro. areas; the impact of CARE Act prov. that limit annual funding decreases; the potential shifts in funding among grantees if HIV case counts were incorp. with the AIDS cases that are currently used in funding formulas; & the variation in eligibility criteria & funding sources among states. Tables.

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DIANE Publishing

Published Date

ISBN 10

1422302393

ISBN 13

9781422302392

Food and Drug Administration

Approval and Oversight of the Drug Mifeprex

By: Marcia Crosse

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Food and Drug Administration

Approval and Oversight of the Drug Mifeprex

By: Marcia Crosse

In Sept. 2000, the FDA approved the drug Mifeprex for use in terminating early term pregnancy. FDA approved the drug under a provision of its Subpart H regulations, allowing it to restrict the drug¿s distribution to assure its safe use. Critics argued that Mifeprex does not fit within the scope of Subpart H, which applies to drugs that treat serious or life-threatening illnesses. This report: (1) describes FDA¿s approval of Mifeprex, including the evidence considered and the restrictions placed on its distribution; (3) compares the Mifeprex approval process to the approval processes for other Subpart H restricted drugs; and (3) compares FDA¿s post-market oversight of Mifeprex to its oversight of other Subpart H restricted drugs. Illustrations.

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DIANE Publishing

Published Date

ISBN 10

1437909108

ISBN 13

9781437909104

Drug Safety

Better Data Management and More Inspections are Needed to Strengthen FDA's Foreign Drug Inspection Program

By: Marcia Crosse

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Drug Safety

Better Data Management and More Inspections are Needed to Strengthen FDA's Foreign Drug Inspection Program

By: Marcia Crosse

The FDA oversees the safety and effectiveness of human drugs marketed in the U.S., including those manufactured in foreign establishments. FDA inspects foreign establishments in order to ensure that the quality of drugs is not jeopardized by poor manufacturing processes. This report examines: (1) the extent to which FDA has accurate data on the number of foreign establishments subject to inspection; (2) the frequency of foreign inspections; and (3) oversight by FDA to ensure that foreign establishments correct serious problems identified during inspections. The author analyzed info. from FDA databases, reviewed inspection reports which identified serious deficiencies, and interviewed FDA officials. Includes recommendations. Illus.

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DIANE Publishing

Published Date

ISBN 10

1437911307

ISBN 13

9781437911305

Ryan White CARE Act: Health Resources and Services Administration’s Implementation of Certain Provisions Hampered by Lack of Timely and Accurate Information

By: Marcia Crosse

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Ryan White CARE Act: Health Resources and Services Administration’s Implementation of Certain Provisions Hampered by Lack of Timely and Accurate Information

By: Marcia Crosse

Under the Ryan White CARE Act, funds are made available to assist over 530,000 individuals affected by HIV/AIDS. Grantees directly provide services to individuals or arrange with service providers to do so. The Health Resources and Services Admin. (HRSA), which administers CARE Act programs, is required to cancel balances of grants that are unobligated after one year and redistribute amounts to grantees in need. Under the CARE Act, states and territories receive grants for AIDS Drug Assistance Programs (ADAP), which provide HIV/AIDS drugs. This report reviews: (1) HRSA's implementation of the unobligated balance provisions; (2) HRSA's actions to collect client-level data; and (3) the status of ADAP waiting lists. Charts and tables.

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DIANE Publishing

Published Date

ISBN 10

1437924115

ISBN 13

9781437924114

Abstinence Education: Assessing the Accuracy and Effectiveness of Federally Funded Programs

Congressional Testimony

By: Marcia Crosse

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Abstinence Education: Assessing the Accuracy and Effectiveness of Federally Funded Programs

Congressional Testimony

By: Marcia Crosse

Among the efforts of the Dept. of Health and Human Services (HHS) to reduce the incidence of sexually transmitted diseases and unintended pregnancies, the agency provides funding to states and organizations that offer abstinence-until-marriage education. This testimony discusses efforts by: (1) HHS and the states to assess the scientific accuracy of materials used in abstinence-until-marriage education programs; and (2) HHS, the states, and researchers to asses the effectiveness of abstinence-until-marriage education programs. Also discusses a Public Health Service Act requirement regarding medically accurate information about condom effectiveness. Illustrations.

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DIANE Publishing

Published Date

ISBN 10

1437904475

ISBN 13

9781437904475

Nonprescription Drugs

Considerations Regarding a Behind-the-Counter Drug Class

By: Marcia Crosse

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Nonprescription Drugs

Considerations Regarding a Behind-the-Counter Drug Class

By: Marcia Crosse

In the U.S., most nonprescription drugs are available over-the-counter in pharmacies and other stores. Experts have suggested that drug availability could be increased by establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed; a similar class of drugs exists in many other countries. This is a report on: (1) arguments supporting and opposing a U.S. BTC drug class; (2) changes in drug availability in 5 countries and the impact of restricted nonprescription classes on availability; and (3) issues important to the establishment of a BTC drug class. The author studied 5 countries: Australia, Italy, the Netherlands, the U.K., and the U.S.

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DIANE Publishing

Published Date

ISBN 10

1437915612

ISBN 13

9781437915617

Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program

Congressional Testimony

By: Marcia Crosse

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Drug Safety: Preliminary Findings Suggest Recent FDA Initiatives Have Potential, But Do Not Fully Address Weaknesses in Its Foreign Drug Inspection Program

Congressional Testimony

By: Marcia Crosse

The FDA is responsible for overseeing the safety and effectiveness of human drugs that are marketed in the U.S., whether they are manufactured in foreign or domestic estab. FDA inspects foreign estab. to ensure that they meet the same standards required of domestic estab. Ongoing concerns regarding FDA¿s foreign drug inspection program recently were heightened when FDA learned that contaminated doses of a common blood thinner had been manufactured at a Chinese estab. that the agency had never inspected. FDA has announced initiatives to improve its foreign drug inspection program. This statement presents preliminary findings on how FDA¿s initiatives address the weaknesses that have been identified. Illustrations.

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DIANE Publishing

Published Date

ISBN 10

1437904343

ISBN 13

9781437904345

Hospital Emergency Departments

Crowding Continues to Occur, and Some Patients Wait Longer Than Recommended Time Frames

By: Marcia Crosse

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Hospital Emergency Departments

Crowding Continues to Occur, and Some Patients Wait Longer Than Recommended Time Frames

By: Marcia Crosse

Of the estimated 119 million visits to U.S. emergency depts. (ED) in 2006, over 40% were paid for by federally-supported programs -- Medicare, Medicaid, and the State Children's Health Insur. Program. There have been reports of crowded conditions in ED often associated with adverse effects on patient quality of care. In 2003, it was reported that most ED in metropolitan areas experienced some degree of crowding. For ex., two out of every three metropolitan hospitals reported going on ambulance diversion -- asking ambulances to bypass their ED and instead transport patients to other facilities. This report examined three indicators of ED crowding - -ambulance diversion, wait times, and patient boarding -- and factors that contribute to crowding. Illus.

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DIANE Publishing

Published Date

ISBN 10

1437917429

ISBN 13

9781437917420

Ryan White CARE Act

Implementation of the New Minority AIDS Initiative Provisions

By: Marcia Crosse

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Ryan White CARE Act

Implementation of the New Minority AIDS Initiative Provisions

By: Marcia Crosse

The Ryan White CARE Act makes fed. funds available to assist individuals affected by HIV/AIDS. Because minorities have been disproportionately affected by HIV/AIDS, the Act's Minority AIDS Initiative (MAI) provides funding with the goal of reducing HIV-related health care disparities among minorities. The reauthor. of CARE Act programs changed the process by which grants are made from a formula based solely on demographics of the metro. area, state, or territory to a competitive process. This report provides info. on: (1) the effect on grantees and service providers of the new competitive process for awarding funds; (2) the types of services grantees funded under MAI; and (3) barriers to minorities obtaining services from HIV/AIDS programs. Illus.

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DIANE Publishing

Published Date

ISBN 10

1437914802

ISBN 13

9781437914801

Food and Drug Administration (FDA)

Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed Were Recently Added

By: Marcia Crosse

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Food and Drug Administration (FDA)

Response to Heparin Contamination Helped Protect Public Health; Controls That Were Needed Were Recently Added

By: Marcia Crosse

In early 2008, the FDA responded to a crisis involving the contamination of heparin, a medication used to prevent and treat blood clots, when the agency received multiple reports of adverse events involving severe allergic reactions. The crisis took place from January 2008 through May 2008, during which time FDA took several actions in its response to the crisis. This report reviewed FDA's management of the heparin crisis. This report examines: (1) how FDA prevented additional contaminated heparin from reaching U.S. consumers; (2) how FDA coordinated its response to the contaminated heparin crisis; and (3) FDA's monitoring and analysis of adverse events associated with heparin. Charts and tables. This is a print on demand report.

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DIANE Publishing

Published Date

ISBN 10

1437942563

ISBN 13

9781437942569

Oversight of Clinical Investigators

Actions Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Med. Report Investigators

By: Marcia Crosse

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Oversight of Clinical Investigators

Actions Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Med. Report Investigators

By: Marcia Crosse

The FDA oversees the clinical investigators who conduct research involving new drugs, biologics, and medical devices to ensure that their conduct does not compromise the safety of clinical trial participants or the integrity of clinical trial data. FDA can debar or disqualify investigators who have engaged in misconduct such as submitting fraudulent data. Debarred or disqualified investigators cannot engage in certain activities related to clinical research. This report reviewed FDA's debarment and disqualification processes. It examined the length of time that debarment and disqualification processes have taken and factors for those time frames, and the statutory and regulatory limitations of debarment and disqualification. Illus.

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DIANE Publishing

Published Date

ISBN 10

1437924654

ISBN 13

9781437924657

Pediatric Drug Research

Studies Conducted Under Best Pharmaceuticals for Children Act

By: Marcia Crosse

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Pediatric Drug Research

Studies Conducted Under Best Pharmaceuticals for Children Act

By: Marcia Crosse

About 2/3 of drugs prescribed for children have not been studied & labeled for pediatric use, which places children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharm. for Children Act (BPCA), encourages the mfrs. of drugs that still have marketing exclusivity to conduct pediatric drug studies (PDS), as requested by the FDA. If they do so, FDA may extend for 6 mo. the period during which no equivalent generic drugs can be marketed. This report: assessed the extent to which PDS were being conducted under BPCA for on-patent drugs; evaluated the impact of BPCA on labeling drugs for pediatric use & the process by which the labeling was changed; & illustrated the range of diseases treated by the drugs studied under BPCA.

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DIANE Publishing

Published Date

ISBN 10

1422317161

ISBN 13

9781422317167

Federal Funds

Fiscal Years 2002-2009 Obligations, Disbursements, and Expenditures for Selected Organizations Involved in Health-Related Activities

By: Marcia Crosse

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Federal Funds

Fiscal Years 2002-2009 Obligations, Disbursements, and Expenditures for Selected Organizations Involved in Health-Related Activities

By: Marcia Crosse

Provides info. on fed. funds provided for FY 2002-09 to selected org. involved in health-related activities and their affiliates: Advocates for Youth, the Guttmacher Inst., the International Planned Parenthood Fdn., the Planned Parenthood Fdn. of Amer., the Population Council, and the Sexuality Info. and Educ. Council of the U.S. Specifically, the report identifies the amount of fed. funds provided to the org. and their affiliates for each of fiscal years 2002-09 and the sources of these fed. funds. The report identified: (1) reported obligations and disbursements of federal funds that the HHS and the USAID provided directly to the selected org.; and (2) expenditures of federal funds reported by org. in instances in which an org. submitted an audit report. Illus.

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DIANE Publishing

Published Date

ISBN 10

1437935044

ISBN 13

9781437935042

Hiv/aids

Federal and State Efforts to Identify Infected Individuals and Connect Them to Care

By: Marcia Crosse

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Hiv/aids

Federal and State Efforts to Identify Infected Individuals and Connect Them to Care

By: Marcia Crosse

Of the 1.1 million Americans living with HIV, not all are aware of their HIV-positive status. Timely testing of HIV-positive individuals is important to improve health outcomes and to slow the disease's transmission. The CDC provides grants to state and local health depts. for HIV prevention. This report examines issues related to identifying individuals with HIV and connecting them to care. It examines: (1) CDC¿s coordination on HIV activities and steps they have taken to encourage routine HIV testing; (2) implementation of routine HIV testing by select state and local health departments; (3) available information on CDC funding for HIV testing; and (4) available data on the number of HIV-positive individuals not receiving care for HIV. Illustrations.

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DIANE Publishing

Published Date

ISBN 10

143792297X

ISBN 13

9781437922974

New Drug Approval

FDA's Consideration of Evidence from Certain Clinical Trials

By: Marcia Crosse

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New Drug Approval

FDA's Consideration of Evidence from Certain Clinical Trials

By: Marcia Crosse

This is a print on demand edition of a hard to find publication. Before approving a new drug, the FDA assesses a drug's effectiveness. To do so, it examines info. contained in a new drug application (NDA), including data from clinical trials in humans. Several types of trials may be used to gather this evidence. Non-inferiority trials aim to demonstrate that the difference between the effectiveness of a new drug and an active control is small enough to show that the new drug is also effective. FDA has issued guidance on these trials. This report: (1) identifies NDAs for new molecular entities -- potentially innovative new drugs not FDA-approved in any form -- that included evidence from non-inferiority trials; (2) examines the characteristics of these trials; and (3) describes FDA's guidance on these trials. Illustrations.

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DIANE Publishing

Published Date

ISBN 10

1437938582

ISBN 13

9781437938586

Antibiotic Resistance (AR)

Data Gaps Will Remain Despite HHS Taking Steps to Improve Monitoring

By: Marcia Crosse

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Antibiotic Resistance (AR)

Data Gaps Will Remain Despite HHS Taking Steps to Improve Monitoring

By: Marcia Crosse

Infections that were once treatable have become more difficult to treat because of AR. AR is accelerated by inappropriate antibiotic use in people. Questions have been raised about whether agencies such as the Dept. of Health and Human Services (HHS) have adequately assessed the effects of antibiotic use and disposal on resistance in humans. This report: (1) describes fed. efforts to quantify the amount of antibiotics produced; (2) evaluates HHS's monitoring of antibiotic use and efforts to promote appropriate use; (3) examines HHS's monitoring of AR infections; and (4) describes fed. efforts to monitor antibiotic disposal and antibiotics in the environ. Charts and tables. This is a print on demand report.

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DIANE Publishing

Published Date

ISBN 10

1437988571

ISBN 13

9781437988574

Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments

Congressional Testimony

By: Marcia Crosse

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Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments

Congressional Testimony

By: Marcia Crosse

As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDA¿s program for inspecting foreign establishments that manufacture medical devices for the U.S. market; and (2) FDA¿s programs for third-party inspections of those establishments.

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DIANE Publishing

Published Date

ISBN 10

1437905277

ISBN 13

9781437905274

Medical Devices: FDA Should Enhance Its Oversight of Recalls

By: Marcia Crosse

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Medical Devices: FDA Should Enhance Its Oversight of Recalls

By: Marcia Crosse

Recalls are an important tool to mitigate serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device. The FDA oversees implementation of the recall. FDA classifies recalls based on health risks of using the recalled device. FDA also determines whether a firm has effectively implemented a recall, and when a recall can be terminated. This report identifies: (1) the numbers and characteristics of medical device recalls and FDA's use of this info. to aid its oversight; and (2) the extent to which the process ensures the effective implementation and termination of the highest-risk recalls. Charts and tables. A print on demand report.

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DIANE Publishing

Published Date

ISBN 10

1437988067

ISBN 13

9781437988062

Lippincott® Illustrated Reviews: Microbiology

By: Cynthia N. Cornelissen,Marcia Metzgar Hobbs

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Lippincott® Illustrated Reviews: Microbiology

By: Cynthia N. Cornelissen,Marcia Metzgar Hobbs

Mastering essential microbiology concepts is easier with this vividly illustrated review resource. Part of the popular Lippincott® Illustrated Reviews series, this proven approach uses clear, concise writing and hundreds of dynamic illustrations to take students inside various microorganisms and ensure success on board exams.

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1204

Publisher

Lippincott Williams & Wilkins

Published Date

ISBN 10

1975139348

ISBN 13

9781975139346

Putting Down Roots

Gardening Insights from Wisconsin’s Early Settlers

By: Marcia C. Carmichael

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Putting Down Roots

Gardening Insights from Wisconsin’s Early Settlers

By: Marcia C. Carmichael

Culture and history can be passed from one generation to the next through the food we eat, the vegetables and fruits we plant and harvest, and the fragrant flowers and herbs that enliven our gardens. The plants our ancestors grew tell stories about their way of life. Wisconsin’s nineteenth-century settlers arrived in the New World in search of new opportunities and the chance to create a new life. These European immigrants and Yankee settlers brought their traditional foodways with them—their family recipes and the seeds, roots, and slips of cherished plants—to serve as comfort food, in the truest sense. This part of our collective history comes alive at Old World Wisconsin’s re-created nineteenth-century heirloom gardens. In Putting Down Roots, historical gardener Marcia C. Carmichael guides us through these gardens, sharing insights on why the owners of the original houses—be they Yankee settlers, German, Norwegian, Irish, Danish, Polish, or Finnish immigrants—planted and harvested what they did. She shares timeless lessons with today’s gardeners and cooks about planting trends and practices, garden tools used by early settlers, popular plant varieties, and favorite flavors of Wisconsin’s early settlers, including recipes for such classics as Irish soda bread, pierogi, and Norwegian rhubarb custard. Putting Down Roots celebrates the diversity and rich ethnic settlement of Wisconsin. It’s also a story of holding fast to one’s traditions and adapting to new ways that nourished one’s family so they could flourish in their new surroundings.

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257

Publisher

Wisconsin Historical Society

Published Date

ISBN 10

0870206613

ISBN 13

9780870206610

James Towne

Struggle for Survival

By: Marcia Sewall

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James Towne

Struggle for Survival

By: Marcia Sewall

This moving account of James Towne's difficult early years is told from the viewpoint of one of its settlers and enhanced by original quotations. During the first summer of 1607, half the James Towne colony died; food was scarce, and the settlers battled oppressive heat and sickness. Over the next few years, supply ships from England became the colony's lifeline, as they brought much-needed stores of food and carried back offerings from the new land, as well as the settlers' homesick letters. Conditions began to improve when Captain John Smith was elected president of the colony, and James Towne soon doubled in size. While some of the settlers had been reluctant to work, Smith required participation from all, and the colonists began to take pride in improving their conditions. Furthermore, by learning the native language and befriending a Native American girl named Pocahontas, Smith was able to establish, temporarily, an uneasy peace between the settlers and the natives whose land they had taken. As new settlers began to arrive from England though, the resources of the budding colony were strained, and in the autumn of 1609 the colony suffered a Starving Time. Deciding to abandon James Towne at last, the colonists headed back toward England, only to have their journey intercepted by a messenger, who informed the settlers that new leaders sent by the King were due to arrive in the flailing colony any day, and urged them to return. Not for long after their arrival, the discouraged James Towne colonists were met by a new governor and a ship full of healthy passengers with enough supplies and hope to work together to ensure James Towne's survival.

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Publisher

Simon and Schuster

Published Date

ISBN 10

1481419692

ISBN 13

9781481419697

Strategies for Showing

Women, Possession, and Representation in English Visual Culture, 1665-1800

By: Marcia R. Pointon

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Strategies for Showing

Women, Possession, and Representation in English Visual Culture, 1665-1800

By: Marcia R. Pointon

In this unusual and original study, Marcia Pointon examines the cultural effects and consequences of the participation by women in acts of representation in the late seventeenth and eighteenth centuries. She explores their lives and work, and a cultural environment in which images of female saints and goddesses established indices of femininity in the homes of wealthy men. Did the women portrayed also possess artifacts, and did they use the power of gifts and bequests to determine social relations? Did they themselves participate in the processes of creating images of the seen world? Pointon sets out to answer some of these questions through a series of novel and vividly recounted case studies of women such as Emma Hamilton (wife and mistress), Mary Moser, the artist, and Dorothy Richardson, the antiquarian.

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468

Publisher

Clarendon Press

Published Date

ISBN 10

019817411X

ISBN 13

9780198174110

Public Health Nursing E-Book

By: Marcia Stanhope,Jeanette Lancaster

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Public Health Nursing E-Book

By: Marcia Stanhope,Jeanette Lancaster

**Selected for Doody's Core Titles® 2024 in Community Health** Gain a solid understanding of community and public health nursing with this industry-standard text! Public Health Nursing: Population-Centered Health Care in the Community, 11th Edition, provides up-to-date information on issues such as infectious diseases, natural and man-made disasters, and healthcare policies affecting individuals, families, and communities. This edition has been thoroughly updated to reflect current data, issues, trends, and practices presented in an easy-to-understand, accessible format. Additionally, real-life scenarios show examples of health promotion and public health interventions, and case studies for the Next-Generation NCLEX® Examination help strengthen your clinical judgment. Ideal for BSN and Advanced Practice Nursing programs, this comprehensive, bestselling text will provide you with a greater understanding of public health nursing! - Focus on Quality and Safety Education for Nurses boxes give examples of how quality and safety goals, competencies, and objectives, knowledge, skills, and attitudes can be applied in nursing practice in the community. - Evidence-Based Practice boxes illustrate the use and application of the latest research findings in public/community health nursing. - Healthy People boxes describe federal health and wellness goals and objectives. - Check Your Practice boxes feature a scenario and questions to promote active learning and encourage students to use clinical judgment skills as they contemplate how to best approach the task or problem in the scenario. - Linking Content to Practice boxes describe the nurse's role in a variety of public and community health areas, giving specific examples of the nurse's role in caring for individuals, families, and populations. - UNIQUE! Separate chapters covering promoting healthy communities, the Intervention Wheel, and nurse-led health centers teach students the initiatives and various approaches to population and community-centered nursing care. - Levels of Prevention boxes address the primary, secondary, and tertiary levels of community/public health nursing as related to chapter content. - How To boxes provide practical application to practice. - End-of-chapter Practice Application scenarios, Key Points, and Clinical Judgment Activities promote application and in-depth understanding of chapter content.

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947

Publisher

Elsevier Health Sciences

Published Date

ISBN 10

0323884180

ISBN 13

9780323884181

Influenza Pandemic

Efforts Under Way to Address Constraints on Using Antivirals and Vaccines to Forestall a Pandemic

By: Marcia Crosse

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Influenza Pandemic

Efforts Under Way to Address Constraints on Using Antivirals and Vaccines to Forestall a Pandemic

By: Marcia Crosse

Pandemic influenza poses a threat to public health at a time when the U.N.¿s World Health Organization has said that infectious diseases are spreading faster than at any time in history. The last major influenza pandemic occurred from 1918 to 1919. Estimates of deaths worldwide if a similar pandemic were to occur have ranged between 30 million and 384 million people. Individual countries and international organizations have developed and begun to implement a strategy for forestalling the onset of a pandemic. Antivirals and vaccines may help do so. This report examines: (1) constraints upon the use of antivirals and vaccines to forestall a pandemic; and (2) efforts under way to overcome these constraints. Charts and tables.

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DIANE Publishing

Published Date

ISBN 10

1437900062

ISBN 13

9781437900064

Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections

Congressional Testimony

By: Marcia Crosse

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Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections

Congressional Testimony

By: Marcia Crosse

As part of the FDA¿s oversight of the safety & effectiveness of medical devices marketed in the U.S., it inspects domestic & foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee & Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. This statement: (1) assesses FDA¿s mgmt. of inspections of establishments -- particularly those in foreign countries -- manufacturing devices for the U.S. market; & (2) provides the status of FDA¿s programs for third-party inspections of medical device manufacturing establishments. Illustrations.

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DIANE Publishing

Published Date

ISBN 10

1437900208

ISBN 13

9781437900200

Drug Safety

FDA Needs to Further Address Shortcomings in Its Postmarket Decisionmaking Process: Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U. S. House of Representatives

By: Marcia Crosse

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Drug Safety

By: Marcia Crosse

Statement of Marcia Crosse, Dir., Health Care, GAO. In 2004, several high-profile drug safety cases raised concerns about the Food & Drug Admin.¿s (FDA) ability to manage postmarket drug safety issues. In some cases there were disagreements within FDA about how to address these issues. GAO was asked to testify on the effectiveness of FDA¿s postmarket decision-making process. This testimony is based on the GAO report, ¿Drug Safety: Improvement Needed in FDA¿s Postmarket Decisionmaking & Oversight Process,¿ which focused on the complex interaction between the two offices within FDA that are involved in postmarket drug safety activities: the Office of New Drugs (OND), & the Office of Drug Safety (ODS). OND¿s primary responsibility is to review new drug applications, but it is also involved in monitoring the safety of marketed drugs. ODS is focused primarily on postmarket drug safety issues. ODS is now called the Office of Surveillance & Epidemiology.

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DIANE Publishing

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ISBN 10

1422315622

ISBN 13

9781422315620

Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure

By: Marcia Crosse

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Influenza Vaccine: Federal Investments in Alternative Technologies and Challenges to Development and Licensure

By: Marcia Crosse

Production delays for the 2009 H1N1 pandemic vaccine using the current egg-based production technology heightened interest in alternative technologies that could expand the supply or accelerate the availability of influenza vaccine. Within the federal government, the Dept. of Health and Human Services (HHS) and the Dept. of Defense (DOD) support the development of technologies that can be used in producing technologies that can be used in producing influenza vaccines. HHS’s Food and Drug Admin. (FDA) reviews licensing applications for new vaccine, and the Dept. of State is the U.S. diplomatic liaison to the international entity that declares worldwide pandemics. This report examines (1) federal funding from FY 2005 through March 2011 for alternative technologies and the status of manufacturers’ efforts, (2) challenges to development and licensure identified by stakeholders, and (3) how HHS is addressing those challenges. Tables and figures. This is a print on demand report.

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1437988296

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