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

nlm:nlmuid-101719834-pdf

6. Anthrax: developing drugs for prophylaxis of inhalational anthrax

nlm:nlmuid-101734212-pdf

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

nlm:nlmuid-101713206-pdf

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

nlm:nlmuid-101733968-pdf

13. Bioanalytical method validation

nlm:nlmuid-101734209-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101734084-pdf

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

nlm:nlmuid-101734398-pdf

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

nlm:nlmuid-101719787-pdf

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

nlm:nlmuid-101734269-pdf

22. Complicated urinary tract infections: developing drugs for treatment

nlm:nlmuid-101734286-pdf

25. 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

nlm:nlmuid-101734092-pdf

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

nlm:nlmuid-101719884-pdf

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

nlm:nlmuid-101713256-pdf

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

nlm:nlmuid-101719840-pdf

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

nlm:nlmuid-101734304-pdf

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

nlm:nlmuid-101734048-pdf

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

nlm:nlmuid-101734090-pdf

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101734075-pdf

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

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

nlm:nlmuid-101734317-pdf

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

nlm:nlmuid-101734078-pdf

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

nlm:nlmuid-101719889-pdf

72. 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

nlm:nlmuid-101719989-pdf

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

nlm:nlmuid-101719987-pdf

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

nlm:nlmuid-101719888-pdf

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

nlm:nlmuid-101704838-pdf

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

nlm:nlmuid-101734070-pdf

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

nlm:nlmuid-101713272-pdf

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

nlm:nlmuid-101713306-pdf

84. 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

nlm:nlmuid-101713277-pdf

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

nlm:nlmuid-101713281-pdf

86. 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

nlm:nlmuid-101713288-pdf

87. 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

nlm:nlmuid-101713291-pdf

88. 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

nlm:nlmuid-101713296-pdf

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

nlm:nlmuid-101713299-pdf

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

nlm:nlmuid-101713430-pdf

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

nlm:nlmuid-101713302-pdf

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

nlm:nlmuid-101719926-pdf

98. 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

nlm:nlmuid-101719954-pdf

99. 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

nlm:nlmuid-101719815-pdf

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

nlm:nlmuid-101704830-pdf