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1. An evidence-based health care system: the case for clinical trials registries : Office of Medical Applications of Research, National Institutes of Health [and] National Library of Medicine, Lister Hill Auditorium, Bethesda, Maryland, December 6-7, 1993

nlm:nlmuid-101120654-bk

7. Preliminary report on the vaccination of man against equine encephalomyelitis (western type)

nlm:nlmuid-35021130R-bk

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

nlm:nlmuid-101712948-pdf

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101713206-pdf

13. 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

14. Palliative care in the outpatient setting: a comparative effectiveness report : final report

nlm:nlmuid-101704627-pdf

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

nlm:nlmuid-101734084-pdf

17. Anthrax: developing drugs for prophylaxis of inhalational anthrax

nlm:nlmuid-101734212-pdf

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

nlm:nlmuid-101734269-pdf

19. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

nlm:nlmuid-101734357-pdf

21. Use of electronic health record data in clinical investigations

nlm:nlmuid-101734386-pdf

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

nlm:nlmuid-101734398-pdf

23. Allergic rhinitis: developing drug products for treatment

nlm:nlmuid-101734438-pdf

25. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101734447-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101719926-pdf

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

nlm:nlmuid-101719981-pdf

31. Chimeric antigen receptor T-cell therapy for B-cell cancers: effectiveness and value : final evidence report

nlm:nlmuid-101744954-pdf

32. Modulator treatments for cystic fibrosis: effectiveness and value : final evidence report and meeting summary

nlm:nlmuid-101744956-pdf

33. Calcitonin gene-related peptide (CGRP) inhibitors as preventive treatments for patients with episodic or chronic migraine: effectiveness and value : final evidence report

nlm:nlmuid-101744957-pdf

34. Targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis: effectiveness and value : condition update : final evidence report

nlm:nlmuid-101745013-pdf

35. Inotersen and patisiran for hereditary transthyretin amyloidosis: effectiveness and value : final evidence report

nlm:nlmuid-101745015-pdf

36. Implantable devices: regulatory framework and reform options

nlm:nlmuid-101747805-pdf

37. Opioid use disorder: developing depot buprenorphine products for treatment

nlm:nlmuid-101759999-pdf

38. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products

nlm:nlmuid-101760015-pdf

39. Pediatric HIV infection: drug product development for treatment

nlm:nlmuid-101760019-pdf

40. Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis

nlm:nlmuid-101760020-pdf

41. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

nlm:nlmuid-101760029-pdf

42. Maximal usage trials for topically applied active ingredients being considered for inclusion in an over-the -counter monograph: study elements and considerations

nlm:nlmuid-101760101-pdf

43. Considerations in demonstrating interchangeability with a reference product

nlm:nlmuid-101760108-pdf

44. Premarket tobacco product applications for electronic nicotine delivery systems

nlm:nlmuid-101760254-pdf

46. Delayed graft function in kidney transplantation: developing drugs for prevention

nlm:nlmuid-101760258-pdf

47. Live case presentations during investigational device exemption (IDE) clinical trials: guidance for institutional review boards, industry, clinical investigators, and Food and Drug administration staff

nlm:nlmuid-101760271-pdf

50. Drugs for treatment of partial onset seizures: full extrapolation of efficacy from adults to pediatric patients 2 years of age and older

nlm:nlmuid-101760399-pdf

51. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

nlm:nlmuid-101760537-pdf

52. Smallpox (variola virus) infection: developing drugs for treatment or prevention

nlm:nlmuid-101760558-pdf

53. Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions

nlm:nlmuid-101767654-pdf

56. Human gene therapy for hemophilia

nlm:nlmuid-101767661-pdf