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15. WIC reauthorization: opportunities for improving the nutritional status of women, infants, and children

31. Rebalancing long-term care: the role of the Medicaid HCBS waiver program

33. Medicare and mental health: the fundamentals

34. Value-based coverage policy in the United States and the United Kingdom: different paths to a common goal

35. Health care price transparency and price competition

37. The prescription drug safety net: access to pharmaceuticals for the uninsured

41. Shaping Medicaid and SCHIP through waivers: the fundamentals

42. The Ryan White HIV/AIDS Program: the basics

46. The Medicare drug benefit coverage gap: the basics

47. National spending for long-term services and supports (LTSS): the basics

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

50. Advancement of emerging technology applications for pharmaceutical innovation and modernization

51. Compliance policy for required warning statements on small-packaged cigars

52. Center for Devices and Radiological Health appeals processes: questions and answers about 517A : guidance for industry and Food and Drug Administration staff

53. Developing and responding to deficiencies in accordance with the least burdensome provisions: guidance for industry and Food and Drug Administration staff

54. Requests for feedback on medical device submissions: the pre-submission program and meetings with Food and Drug Administration staff : guidance for industry and Food and Drug Administration staff

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

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

57. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

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

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

61. De novo classification process (evaluation of automatic class III designation): guidance for industry and Food and Drug Administration staff

62. Product labeling for certain ultrasonic surgical aspirator devices: guidance for Industry and Food and Drug Administration staff

63. Manufacturers sharing patient-specific information from medical devices with patients upon request: guidance for industry and Food and Drug Administration staff

64. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice

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

67. Recurrent herpes labialis: developing drugs for treatment and prevention

68. Evaluating drug effects on the ability to operate a motor vehicle

69. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

70. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

71. Unique device identification: direct marking of devices : guidance for Industry and Food and Drug administration staff

72. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

73. Pediatric information for x-ray imaging device premarket notifications: guidance for industry and Food and Drug Administration staff

74. Nucleic acid testing (NAT) for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV): testing, product disposition, and donor deferral and reentry

75. 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

76. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

77. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

78. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff

80. Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria labeling for NDAs and ANDAs

81. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

82. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

83. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

84. Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

87. Drinking water: EPA should strengthen ongoing efforts to ensure that consumers are protected from lead contamination : report to congressional requesters

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

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

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

95. Round 2 competitive bidding for CPAP/RAD: disrupted access unlikely for devices, inconclusive for supplies

97. OHRP generally conducted its compliance activities independently, but changes would strengthen its independence

98. HHS's Office of Refugee Resettlement improved coordination and outreach to promote the safety and well-being of unaccompanied alien children

99. Medicare program shared savings accountable care organizations have shown potential for reducing spending and improving quality