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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

8. Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters

nlm:nlmuid-101713330-pdf

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

nlm:nlmuid-101733968-pdf

14. Bioanalytical method validation

nlm:nlmuid-101734209-pdf

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

nlm:nlmuid-101719919-pdf

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

nlm:nlmuid-101734084-pdf

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

nlm:nlmuid-101734398-pdf

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

nlm:nlmuid-101719787-pdf

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

nlm:nlmuid-101734269-pdf

25. Complicated urinary tract infections: developing drugs for treatment

nlm:nlmuid-101734286-pdf

28. Connecting kids to health coverage: evaluating the Child Health and Disability Prevention Gateway program

nlm:nlmuid-101322641-pdf

29. 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

32. 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

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

nlm:nlmuid-101713256-pdf

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

nlm:nlmuid-101719840-pdf

38. 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

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

nlm:nlmuid-101734048-pdf

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

nlm:nlmuid-101734090-pdf

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

nlm:nlmuid-101712951-pdf

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

nlm:nlmuid-101734075-pdf

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

nlm:nlmuid-101712946-pdf

48. Emerging infectious diseases: actions needed to ensure improved response to Zika virus disease outbreaks : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

nlm:nlmuid-101713412-pdf

51. 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

53. 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

56. 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

58. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices

nlm:nlmuid-101738136-pdf

61. Financing county Medi-Cal eligibility and enrollment in California

nlm:nlmuid-101604079-pdf

63. 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

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

nlm:nlmuid-101719981-pdf

66. 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

67. Generic drug user fees: application review times declined, but FDA should develop a plan for administering its unobligated user fees : report to the Chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate

nlm:nlmuid-101726929-pdf

70. 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

71. Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees

nlm:nlmuid-101727012-pdf

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

nlm:nlmuid-101734088-pdf

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

nlm:nlmuid-101734317-pdf

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

nlm:nlmuid-101734078-pdf

80. 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

81. Measuring up?: end-of-life cancer care in California

nlm:nlmuid-101628683-pdf

83. Memory supplements: clarifying FDA and FTC roles could strengthen oversight and enhance consumer awareness : report to Congressional requesters

nlm:nlmuid-101726917-pdf

88. 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

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

nlm:nlmuid-101719987-pdf

90. Physician assistants and nurse practitioners in specialty care: six practices make it work

nlm:nlmuid-101516785-pdf

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

nlm:nlmuid-101719888-pdf

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

nlm:nlmuid-101704838-pdf

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

nlm:nlmuid-101734070-pdf

100. 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