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

nlm:nlmuid-101719834-pdf

7. 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

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

nlm:nlmuid-101490538-pdf

9. 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

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

nlm:nlmuid-101703988-pdf

15. Anthrax: developing drugs for prophylaxis of inhalational anthrax

nlm:nlmuid-101734212-pdf

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

nlm:nlmuid-101713206-pdf

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

nlm:nlmuid-101713360-pdf

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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters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

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

nlm:nlmuid-101733968-pdf

27. Bioanalytical method validation

nlm:nlmuid-101734209-pdf

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

nlm:nlmuid-101727231-pdf

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

nlm:nlmuid-101737763-pdf

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

nlm:nlmuid-101738059-pdf

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

nlm:nlmuid-101737750-pdf

41. Child well-being: key considerations for policymakers including the need for a federal cross-agency priority goal : a report to Congress

nlm:nlmuid-101746148-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101734084-pdf

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

nlm:nlmuid-101734398-pdf

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

nlm:nlmuid-101719787-pdf

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

nlm:nlmuid-101477700-pdf

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

nlm:nlmuid-101734269-pdf

62. Complicated urinary tract infections: developing drugs for treatment

nlm:nlmuid-101734286-pdf

65. 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

67. Counternarcotics: overview of U.S. efforts in the Western Hemisphere : report to the ranking member, Committee on Foreign Affairs, House of Representatives

nlm:nlmuid-101746124-pdf

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

nlm:nlmuid-101737746-pdf

71. 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

73. 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

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

nlm:nlmuid-101713256-pdf

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

nlm:nlmuid-101719840-pdf

81. 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

82. 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

83. 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

84. 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

85. Drug industry: profits, research and development spending, and merger and acquisition deals : report to Congressional requesters

nlm:nlmuid-101746249-pdf

88. 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

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

nlm:nlmuid-101734048-pdf

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

nlm:nlmuid-101734090-pdf

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101734075-pdf

95. 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

96. 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