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

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

21. Medicare and mental health: the fundamentals

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

23. Health care price transparency and price competition

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

29. Shaping Medicaid and SCHIP through waivers: the fundamentals

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

34. The Medicare drug benefit coverage gap: the basics

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

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

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

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

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

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

42. 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

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

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

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

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

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

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

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

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

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

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

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

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

57. 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

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

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

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

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

62. 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

63. 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

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

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

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

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

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

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

71. 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

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

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

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

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

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

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

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

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

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

89. As funding for BPA research increased, NIEHS followed its peer review process while also exercising its discretion

91. Medicare Part B drug payments: impact of price substitutions based on 2014 average sales prices

93. Drug supply chain security: wholesalers exchange most tracing information

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

99. A few states fell short in timely investigation of the most serious nursing home complaints: 2011-2015