Tabla de Contenidos: “…Identifying Sources of Inefficiency CHAPTER THREE: The Legal and Institutional Settings; Food and Drug Administration Regulation; Preapproval Regulations; Post-Market Regulations; Product-Liability Law for Prescription Drugs; Manufacturing Defects; Design Defects; Warnings Defects; Regulatory Compliance Defenses (RCDs); Other Legal Issues and Practices; Personal-Injury Causation; Class Actions Alleging Personal Injuries; Class Actions Alleging Financial Injuries; Judicial Gatekeeping of Expert Evidence; U.S. …”

Tabla de Contenidos: “…; Chapter Two: The Context for Medical Product Innovation; Three Stages of Innovation; Primary Actors in Inventing Medical Products; Drug and Device Companies; HIT Companies; Goals of Medical Product Inventors; Private Investors; Financial Incentives of Medical Product Inventors; Influencers of Medical Product Invention; National Institutes of Health; U.S. Food and Drug Administration…”

Tabla de Contenidos: “…Agency for International Development -- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration -- Centers for Disease Control and Prevention -- U.S. …”

“…At the request of the U.S. Food and Drug Administration, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products considers the likely public health impact of raising the minimum age for purchasing tobacco products. …”

Tabla de Contenidos: “…Department of Agriculture -- Food Safety and Inspection Service -- National Animal Health Monitoring System -- Market Cattle Identification Program -- Food and Drug Administration -- Shellfish Monitoring Programs -- The National Animal Poison Information Network -- Outbreak Investigation -- Methyl Mercury in Fish -- Polychlorinated Biphenyls in Chickens -- Polybrominated Biphenyls in Cattle -- ANALYTIC EPIDEMIOLOGIC STUDIES -- Sheep and Heavy Metals -- Cattle and Heavy Metals -- Cattle and Fluoride -- SUMMARY -- 4 Companion Animals as Sentinels -- DESCRIPTIVE EPIDEMIOLOGIC STUDIES -- Veterinary Medicine Data Program -- Poison-Control Centers -- ANALYTIC EPIDEMIOLOGIC STUDIES -- Canine Mesothelioma and Asbestos Exposure -- Canine Bladder Cancer and Insecticide Exposure -- Lead Poisoning -- Breast Cancer in Dogs -- Diet and Risk of Breast Cancer -- Diet and Survival with Breast Cancer -- Birds and Polytetrafluoroethylene Exposure -- Low-Level Radiation and Cancer -- Cancer in Vietnam-Service Dogs -- Animal Neoplasm Registry -- SUMMARY -- 5 Fish and Other Wildlife as Sentinels -- DESCRIPTIVE EPIDEMIOLOGIC STUDIES -- National Programs -- National Status and Trends Program -- Mussel Watch -- National Contaminant Biomonitoring Program -- Registry of Tumors in Lower Animals -- Penrose Laboratory of Comparative Pathology -- Quarterly Wildlife Mortality Report -- State/Regional/Local Programs -- Great Lakes -- Chesapeake Bay -- Puget Sound -- Sacramento-San Joaquin Estuary -- ANALYTIC EPIDEMIOLOGIC STUDIES -- Initial Identification of Hazardous Agents…”

Tabla de Contenidos:

Tabla de Contenidos: “…Oral Contraceptives &amp -- Breast Cancer -- Copyright -- Preface -- Contents -- Executive Summary -- MAINTAINING SURVEILLANCE -- DEVELOPING A BROADER ARRAY OF CONTRACEPTIVES -- ASSESSING KNOWLEDGE FOR APPLICATION IN CLINICAL PRACTICE -- FILLING GAPS IN BIOLOGICAL AND EPIDEMIOLOGICAL KNOWLEDGE -- 1 Introduction and Overview -- BIOLOGICAL PLAUSIBILITY OF A LINK BETWEEN ORAL CONTRACEPTIVES AND BREAST CANCER -- WHAT IS-AND IS NOT-KNOWN -- SEEKING ANSWERS -- 2 Epidemiology: Information Needs and Data Gaps -- EPIDEMIOLOGICAL RESEARCH -- Case-Control Method -- Cohort Studies -- Comparison Groups -- Ecological Studies -- Special Studies -- Women Exposed to Hormones Other than Oral Contraceptives -- Women Genetically Susceptible to Breast Cancer -- Estrogen Metabolism -- Progestins -- Changing Oral Contraceptive Formulations -- SUMMARY AND CONCLUSIONS -- 3 Biology: Information Needs and Data Gaps -- SIGNAL COMPLEXITY IN BREAST REGULATION -- RESEARCH ISSUES -- Relationships Among Cell Types -- Receptors -- Timing -- Effects of Pregnancy and Lactation -- Pathological Breast Tissue -- Oncogenes -- Molecular Changes Associated with Human Breast Cancer -- Activated ras Mutations -- Overexpression of Tyrosine Kinases -- Amplification of int-2 and myc -- Deletions of Genes -- RESEARCH MODELS -- Breast Cancer Cell Lines -- Short-term Culture of Normal Mammary Epithelium -- Organ Culture -- Nude Mouse Model -- SUMMARY AND CONCLUSIONS -- 4 Information for Users of the Pill and Health Care Providers -- BENEFITS AND RISKS OF ORAL CONTRACEPTIVES -- Benefits -- Risks -- CURRENT CONTROVERSY -- PRESCRIBING PROBLEMS -- 5 Policy Issues and Recommendations -- MAINTAINING SURVEILLANCE -- Cooperative Research -- Surveillance Requirements of the Food and Drug Administration -- DEVELOPING A BROADER ARRAY OF CONTRACEPTIVES…”

Tabla de Contenidos: “…Intro -- Table of Contents -- About the Author -- About the Technical Reviewers -- Introduction -- Chapter 1: Healthcare Market: A Primer -- Different Stakeholders of the Healthcare Marketplace -- Regulators -- Food and Drug Administration (FDA) -- Center for Medicare and Medicaid Services (CMS) -- Center for Medicare and Medicaid Innovation (CMMI) -- Payers -- Providers -- Regulation of Healthcare Information -- AI Applications in Healthcare -- Screening -- Diagnosis -- Prognosis -- Response to Treatment -- What Is the Industry Landscape? …”

Tabla de Contenidos: “…AVOIDING UNREASONABLE PATIENT EXPECTATIONS -- SUMMARY AND CONCLUSIONS -- REFERENCES -- 8 Ethical and Societal Issues -- ISSUES RAISED BY INCOMPLETE TECHNOLOGIES -- Maximizing Benefits in the Provision of Health Care -- Conceptualizing Access to Incomplete Technologies -- ISSUES RAISED BY THE TOTAL ARTIFICIAL HEART -- Access to Total Artificial Hearts -- Criteria for Use -- Aggregate Societal Costs -- PROTECTING THE INDIVIDUAL PATIENT -- Informed Consent and Advance Directives -- CONCLUSIONS -- REFERENCES -- 9 Roles of Government and Industry in Medical Technology Research, Development, and Use -- ROLE OF THE FEDERAL GOVERNMENT IN THE DEVELOPMENT OF MEDICAL TECHNOLOGY -- Rationale for Federal Support of Research and Development -- Theoretical Considerations -- Practical Implications -- Status of the Artificial Heart Program -- Management and Accountability -- Social (Health) Benefits -- Industrial-Policy Considerations -- Conclusions -- ROLE OF GOVERNMENT IN THE USE OF MEDICAL TECHNOLOGY -- Food and Drug Administration -- Medicare and Other Third-Party Payers -- Conclusions About Regulatory Constraints -- ENCOURAGING INTERDISCIPLINARY AND INDUSTRY-ACADEME COLLABORATION -- Role of Biomedical Engineering Research -- Current Collaborative Structures -- Conclusions About Collaborative Research -- EFFECT OF INDUSTRY SUPPORT ON COMMUNICATION AMONG RESEARCHERS -- Conclusions -- SUMMARY AND CONCLUSIONS -- REFERENCES -- 10 Conclusions and Recommendations -- FOCUS OF THIS STUDY -- PROMOTING APPROPRIATE USE OF MECHANICAL CIRCULATORY SUPPORT DEVICES -- ACCESS BY ALL TO CIRCULATORY SUPPORT DEVICES? …”

Tabla de Contenidos: “…Batchelor, Jeffrey G. Supko -- Food and drug administration role in oncology product development / Thomas G. …”
Enlace del recurso

Tabla de Contenidos: “…3.2 ISO and ANSI -- 3.2.1 ISO Standards -- 3.2.2 ISO Standards for Cleaning and Contamination Control -- 3.3 China Food and Drug Administration -- 3.3.1 CFDA Pharmaceutical Standard -- 4 Standards Evolution -- 5 Interpreting Standards -- 5.1 Interpretation of Cleanroom Standards -- 5.1.1 Other Standards -- 5.1.2 What Is the Product Surface? …”

Tabla de Contenidos: “…. -- CONTENTS -- INTRODUCTION -- GOVERNMENT AGENCIES -- Federal Agencies -- Agency for Toxic Substances and Disease Registry -- Centers for Disease Control and Prevention -- Consumer Product Safety Commission -- Department of Energy -- Department of Health and Human Services -- Environmental Protection Agency -- Food and Drug Administration -- Health Resources and Services Administration -- National Cancer Institute -- National Center for Environmental Health -- National Institute for Occupational Safety and Health -- The National Institute of Environmental Health Sciences -- National Institutes of Health -- National Institute of Nursing Research -- Nuclear Regulatory Commission -- Occupational Safety and Health Administration -- State Agencies -- State Health Departments and Radon Contacts -- Environmental Council of States (ECOS Member States Directory) -- ASSOCIATIONS AND ORGANIZATIONS -- American Academy of Nurse Practitioners -- American Academy of Nursing -- American Assembly for Men in Nursing -- American Association of Colleges of Nursing -- American Association of Occupational Health Nurses -- American Association of Poison Control Centers -- American Board for Occupational Health Nurses -- American Cancer Society -- American College of Obstetricians and Gynecologists -- American College of Occupational and Environmental Medicine -- American Lung Association -- American Nurses Association -- American Nurses Foundation…”

Tabla de Contenidos: “…2 Methods for Priority Setting -- PRIORITY-SETTING PROCESSES USED BY ORGANIZATIONS -- Example 1: Health Care Financing Administration -- Bureau of Policy Development -- Health Care Financing Administration Physicians Panel -- Reevaluation or Assessment of Established Technologies -- Example 2: Private Sector-Pharmaceutical Industry -- Criteria for Assessment -- Criteria for Reassessment -- Internal Process of Priority Setting -- Example 3: Health Care Provider Organizations -- Example 4: Institute of Medicine/Council on Health Care Technology Pilot Study -- Example 5: Food and Drug Administration -- QUANTITATIVE MODELS FOR SETTING PRIORITIES -- Example 6: Technology Assessment Priority-Setting System -- Example 7: The Phelps-Parente Model -- SETTING PRIORITIES FOR SPENDING ON HEALTH SERVICES -- Example 8: Oregon Basic Health Services Act -- DISCUSSION -- Reactive and Implicit Processes -- Strengths and Weaknesses of Reactive Mechanisms -- The IOM/CHCT Process Compared with This IOM Study -- Analytic Models -- Strengths and Weaknesses of Analytic Models -- Need for a Comprehensive, Proactive Process for Priority Setting -- SUMMARY -- APPENDIX: MEDICARE COVERAGE DECISION MAKING -- 3 Guiding Principles -- BUILDING A MODEL PROCESS FOR SETTING PRIORITIES -- PROCESS BUILDING FOR OHTA -- The Process Must Reflect the Mission of OHTA -- Potential to Reduce Pain, Suffering, and Premature Death -- Potential to Reduce Inappropriate Health Care Expenditures -- Potential to Reduce Inequity and Inform Other Social Issues -- The Product of the Process Should Be Consistent with the Needs of Users -- The Process Must Be Efficient -- The Process Must Be Sensitive to the Environment in Which OHTA Operates -- SUMMARY -- 4 Recommendations for a Priority-Setting Process -- PREVIEW OF THE QUANTITATIVE MODEL -- ELEMENTS OF THE PROPOSED PRIORITY-SETTING PROCESS…”

Tabla de Contenidos: “…Utilization Rates -- Collective Dose -- Radiation Regulation and Control -- Internal Sources: Brachytherapy -- Overview -- Types of Procedures -- Radiation Regulation and Control -- Internal Unsealed Sources: Therapeutic Nuclear Medicine -- Overview -- Types of Procedures and Number of Treatments -- Radiation Regulation and Control -- CHAPTER SUMMARY -- REFERENCES -- 3 Regulation and Radiation Medicine -- REGULATORY GOALS -- THE CURRENT REGULATORY FRAMEWORK -- How Society Regulates Health Care Delivery -- The Regulatory Framework -- Nuclear Regulatory Commission -- Food and Drug Administration -- Environmental Protection Agency -- States -- THE COSTS OF NRC REGULATION -- Cost Recovery by the NRC Through Fee Collection -- Cost of a Full-Time Equivalent at NRC -- Fee Schedules for Selected NRC License Categories -- Fees Collected from Selected NRC License Categories in 1993 -- Fines Collected from Selected NRC License Categories in 1993 -- Non-Fee Costs of NRC Regulation -- Recordkeeping Requirements -- Security Requirements -- Radioactive Waste Management -- Cost Savings Estimates for Some NRC Licensees -- Summary of Fee and Non-Fee Costs of NRC Regulation -- QUALITATIVE ASSESSMENTS OF NRC REGULATIONS -- Criticism of the Regulatory System -- Fragmentation and Disproportionality -- Administrative Requirements -- Fees and Fines -- CHAPTER SUMMARY -- REFERENCES -- 4 Risks of Ionizing Radiation in Medicine -- RISK ASSESSMENT -- Kinds of Radiation Injury -- Human Study Limitations -- Models of Radiation Injury -- The Tolerance Dose, Threshold Model -- Introduction of the Linear, No-Threshold Model -- Summary Observations -- RISKS OF IONIZING RADIATION IN MEDICAL TREATMENT -- Risk of Unintended Exposures in Radiation Medicine -- Human Error and Unintended Events -- Rates of Misadministration…”

Tabla de Contenidos: “…RESPONSIBILITIES OF FEDERAL AGENCIES -- Public Health Service -- Centers for Disease Control -- Food and Drug Administration -- National Institutes of Health -- Agency for Health Care Policy and Research -- Health Care Financing Administration -- Conditions of Coverage -- State Survey Process -- HSQB and the ESRD Networks -- Bureau of Policy Development -- Office of Research and Demonstrations -- Coordination Within HCFA -- Quality Assessment and Assurance Data Needs -- CONTINUOUS QUALITY IMPROVEMENT -- The Dialysis Facility: Practical Considerations -- Examples of ESRD Quality Assurance -- CONCLUSIONS AND RECOMMENDATIONS -- NOTES -- REFERENCES -- APPENDIX 1 QUALITY OF CARE IN ESRD: AN EXAMPLE OF A PROXIMATE CLINICAL INDICATOR -- Treating Anemia in Dialysis Patients1 -- Potential Use as an Outcome Indicator -- Potential Use as Process Indicators -- NOTE -- References -- APPENDIX 2 EXAMPLES OF ESRD QUALITY ASSURANCE -- Dialysis Clinic, Inc., Cincinnati (DCI-C) -- Greenfield Health Systems -- National Medical Care, Inc. …”

Tabla de Contenidos: “…Environmental Protection Agency -- U.S. Food and Drug Administration -- Import control program -- Routine and periodic surveys for residual chemicals -- National Marine Fisheries Service -- Training and Educational Programs…”

Tabla de Contenidos: “…Auflage -- Inhaltsverzeichnis -- 1 Einleitung -- 1.1 Aufbau dieses Buches -- 1.2 Initiative »Certified Professional for Medical Software« (CPMS) -- 1.3 Zuordnung der Kapitel dieses Buches zum Curriculum des CPMS -- 2 Rechtliche Grundlagen -- 2.1 Die Rechtslage in Europa -- 2.1.1 Das sogenannte neue Konzept für Produktregulierung innerhalb der Europäischen Union -- 2.1.2 Regulatorische Landkarte für Medizinprodukte -- 2.2 Regulatorische Vorgaben für Medizinprodukte -- 2.2.1 Die Medizinprodukterichtlinie und die Medizinprodukteverordnung -- 2.2.2 Besonderheiten für aktive implantierbare medizinische Geräte -- 2.2.3 Besonderheiten für In-vitro-Diagnostika -- 2.2.4 Die Gesetzgebung in der Bundesrepublik Deutschland -- 2.3 Harmonisierte Normen -- 2.3.1 Das neue Konzept der Europäischen Union -- 2.3.2 Entstehung von harmonisierten Normen -- 2.3.3 Veröffentlichung von harmonisierten Normen -- 2.4 Relevante harmonisierte Normen -- 2.4.1 Qualitätsmanagement (EN ISO 13485) -- 2.4.2 Risikomanagement (EN ISO 14971) -- 2.4.3 Software-Lebenszyklus-Prozesse (EN 62304) -- 2.4.4 Gebrauchstauglichkeit (EN 62366 und EN 60601-1-6) -- 2.4.5 Normenfamilie EN 60601 über medizinische elektrische Geräte -- 2.5 Anwendung und Kontrolle rechtlicher Vorgaben -- 2.5.1 Lebenszyklus eines Medizinproduktes -- 2.5.2 Überwachung von Herstellern -- 2.5.3 Überwachung von benannten Stellen -- 2.6 Weltweite Harmonisierungsbemühungen - die GHTF und das IMDRF -- 2.7 Die Situation in den USA -- 2.7.1 Aufbau der Gesetzgebung -- 2.7.2 Federal Food, Drug, and Cosmetic Act (FD&amp -- C Act) -- 2.7.3 Code of Federal Regulations Title 21 (21 CFR) -- 2.7.4 Food and Drug Administration (FDA ) -- 2.7.5 Klassifizierung von Medizinprodukten -- 2.7.6 Inverkehrbringen von Medizinprodukten -- 2.7.7 Softwarespezifische Vorgaben…”

Tabla de Contenidos: “…Infractions constatées dans le cadre des détentions d'importations de la Food and Drug Administration..…”

“…This workshop was organized by the Nuclear and Radiation Studies Board of the National Academy of Sciences and sponsored by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, and the U.S. Department of Health and Human Services. …”

“…This has led to a number of efforts--by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)--to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. …”