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

nlm:nlmuid-101719834-pdf

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

nlm:nlmuid-101727190-pdf

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

nlm:nlmuid-101490538-pdf

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

nlm:nlmuid-101727033-pdf

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

nlm:nlmuid-101703988-pdf

13. Anthrax: developing drugs for prophylaxis of inhalational anthrax

nlm:nlmuid-101734212-pdf

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

nlm:nlmuid-101713206-pdf

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

nlm:nlmuid-101713360-pdf

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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

nlm:nlmuid-101713330-pdf

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

nlm:nlmuid-101733968-pdf

24. Bioanalytical method validation

nlm:nlmuid-101734209-pdf

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

nlm:nlmuid-101727231-pdf

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

nlm:nlmuid-101737763-pdf

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

nlm:nlmuid-101738059-pdf

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

nlm:nlmuid-101737750-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101734084-pdf

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

nlm:nlmuid-101734398-pdf

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

nlm:nlmuid-101719787-pdf

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

nlm:nlmuid-101477700-pdf

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

nlm:nlmuid-101734269-pdf

50. Complicated urinary tract infections: developing drugs for treatment

nlm:nlmuid-101734286-pdf

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

nlm:nlmuid-101734092-pdf

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

nlm:nlmuid-101737746-pdf

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

nlm:nlmuid-101719884-pdf

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

nlm:nlmuid-101704071-pdf

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

nlm:nlmuid-101713256-pdf

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

nlm:nlmuid-101719840-pdf

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

nlm:nlmuid-101727247-pdf

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

nlm:nlmuid-101734304-pdf

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

nlm:nlmuid-101727112-pdf

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

nlm:nlmuid-101727091-pdf

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

nlm:nlmuid-101704075-pdf

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

nlm:nlmuid-101734048-pdf

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

nlm:nlmuid-101734090-pdf

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101734075-pdf

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

nlm:nlmuid-101727019-pdf

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

nlm:nlmuid-101727080-pdf

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

nlm:nlmuid-101712946-pdf

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

nlm:nlmuid-101713412-pdf

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

nlm:nlmuid-101737930-pdf

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

nlm:nlmuid-101713268-pdf

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

nlm:nlmuid-101713258-pdf

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

nlm:nlmuid-101737981-pdf

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

nlm:nlmuid-101719990-pdf