U.S. Department of Health & Human Services

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


6. Anthrax: developing drugs for prophylaxis of inhalational anthrax


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


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 Antibiotics: FDA has encouraged development, but needs to clarify the role of draft guidance and develop qualified infectious disease product guidance : report to Congressional requesters


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


14. Bioanalytical method validation


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


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


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


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


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


25. Complicated urinary tract infections: developing drugs for treatment


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


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


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


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


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


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


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


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


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


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


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


49. 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


52. 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


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


58. 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


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


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


67. 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


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


70. 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


71. 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


75. 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


77. Imported seafood safety: FDA and USDA could strengthen efforts to prevent unsafe drug residues : report to the chairman, Committee on Appropriations, U.S. Senate


78. 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


80. Keeping America's food safe: a blueprint for fixing the food safety system at the U.S. Department of Health and Human Services


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


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


85. Low-dose radiation: interagency collaboration on planning research could improve information on health effects : testimony before the Subcommittee on Energy, Committee on Science, Space, and Technology, House of Representatives


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


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


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


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


98. 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


99. One percent of drugs with Medicaid reimbursement were not FDA-approved


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