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4. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff


6. Affordable Care Act: IRS should mitigate limitations of data to be used for the age and gender adjustment for the tax on high-cost health plans : report to Congressional committees


7. The aging services network: accomplishments and challenges in serving a growing elderly population


8. Air ambulance: data collection and transparency needed to enhance DOT oversight : report to the Committee on Transportation and Infrastructure, House of Representatives


11. An analysis of private-sector prices for hospital admissions


13. Anthrax: developing drugs for prophylaxis of inhalational anthrax


14. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases


15. Antibiotic resistance: more information needed to oversee use of medically important drugs in food animals : report to Congressional requesters


16. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters


22. BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment


24. Bioanalytical method validation


25. Biodefense: federal efforts to develop biological threat awareness : report to Congressional requesters


28. CDC generally met its inspection goals for the federal select agent program: however, opportunities exist to strengthen oversight


29. CMS did not detect some inappropriate claims for durable medical equipment in nursing facilities


30. CMS validated hospital inpatient quality reporting program data, but should use additional tools to identify gaming


39. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment


40. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool


41. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases


42. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff


45. Community-based long-term care: Wisconsin stays ahead : site visit report


49. Complicated intra-abdominal infections: developing drugs for treatment


50. Complicated urinary tract infections: developing drugs for treatment


53. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff


56. Data inadequacies undermine CMS's oversight of the inconsistency resolution process for the federal marketplace


58. Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff


60. Defense civil support: DOD, HHS, and DHS should use existing coordination mechanisms to improve their pandemic preparedness : report to the Committee on Armed Services, House of Representatives


61. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff


64. Display devices for diagnostic radiology: guidance for industry and Food and Drug Administration staff


66. Drinking water: DOD has acted on some emerging contaminants but should improve internal reporting on regulatory compliance : report to Congressional committees


67. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff


68. Drug control policy: information on status of federal efforts and key issues for preventing illicit drug use : testimony before the Committee on Oversight and Government Reform, House of Representatives


69. Drug discount program: update on agency efforts to improve 340B program oversight : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives


72. Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees


73. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment


74. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population


75. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)


78. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)


79. Early learning and child care: agencies have helped address fragmentation and overlap through improved coordination : report to the Chairwoman, Committee on Education and the Workforce, House of Representatives


80. Early learning and child care: overview of federal investment and agency coordination : testimony before the Subcommittee on Early Childhood, Elementary, and Secondary Education, Committee on Education and the Workforce, House of Representatives


85. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders


86. Emerging infectious diseases: actions needed to ensure improved response to Zika virus disease outbreaks : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives


88. Enhancements needed in the tracking and collection of Medicare overpayments identified by ZPICS and PSCS


92. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff


94. Evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies: guidance for Industry and Food and Drug Administration staff


96. Excluding noncovered versions when setting payment for two Part B drugs would have resulted in lower drug costs for Medicare and its beneficiaries


99. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff