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

nlm:nlmuid-101712946-pdf

45. 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

nlm:nlmuid-101713268-pdf

47. 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

49. 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

nlm:nlmuid-101719990-pdf

52. 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

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

nlm:nlmuid-101719981-pdf

55. 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

58. 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

nlm:nlmuid-101713098-pdf

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

nlm:nlmuid-101734088-pdf