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1. Health and Human Services funding for abstinence education, education for teen pregnancy, and HIV/STD prevention, and other programs that address adolescent sexual activity

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3. Foster care: HHS has taken steps to support states' oversight of psychotropic medications, but additional assistance could further collaboration : report to Congressional requesters

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4. 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

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

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6. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

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7. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

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

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9. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

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

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12. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

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15. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

nlm:nlmuid-101713196-pdf

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

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18. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

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

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

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22. 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

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23. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

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24. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 2(R1) : test for extractable volume of parenteral preparations general chapter

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25. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

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26. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

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27. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

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28. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

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29. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

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30. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

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31. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

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

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34. Medicaid program integrity: CMS should build on current oversight efforts by further enhancing collaboration with states : report to the Chairman, Committee on Finance, U.S. Senate

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35. Pediatric trauma centers: availability, outcomes, and federal support related to pediatric trauma care : report to Congressional requesters

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39. Medicaid personal care services: more harmonized program requirements and better data are needed : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

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40. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

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41. Physician workforce: locations and types of graduate training were largely unchanged, and federal efforts may not be sufficient to meet needs : report to Congressional requesters

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42. Hospital value-based purchasing: CMS should take steps to ensure lower quality hospitals do not qualify for bonuses : report to Congressional committees

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43. 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

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44. Medicare: CMS should evaluate providing coverage for disposable medical devices that could substitute for durable medical equipment : report to Congressional committees

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45. 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

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46. Public health information technology: HHS has made little progress toward implementing enhanced situational awareness network capabilities : report to Congressional committees

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47. Personal firearms: programs that promote safe storage and research on their effectiveness : report to Congressional requesters

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48. Human trafficking: investigations in Indian country or involving Native Americans and actions needed to better report on victims served : testimony before the Committee on Indian Affairs, U.S. Senate

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49. Newborn health: federal action needed to address neonatal abstinence syndrome : report to Congressional addressees

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

nlm:nlmuid-101727231-pdf

51. Navigating recovery: health care financing and delivery systems in Puerto Rico and US Virgin Islands

nlm:nlmuid-101727559-pdf

53. Gauging the progress of the National Health Information Technology Initiative: perspectives from the field

nlm:nlmuid-101492240-pdf

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

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

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61. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

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

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63. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

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

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66. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

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

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68. 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

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69. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

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75. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

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79. Bioanalytical method validation

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81. Anthrax: developing drugs for prophylaxis of inhalational anthrax

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

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83. Complicated urinary tract infections: developing drugs for treatment

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

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86. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

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90. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

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

nlm:nlmuid-101734398-pdf