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61. Assessing user fees under the prescription drug user fee amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Drug Approval
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

62. Controlled correspondence related to generic drug development

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Development
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

63. Spinal plating systems: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020
Subject(s):: Bone Plates
Equipment Design
Equipment Safety
Spinal Cord
Spinal Fusion
Materials Testing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

64. FDA drug approval: application review times largely reflect FDA goals : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, March 2020
Subject(s):: Investigational New Drug Application -- organization & administration
Time Factors
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

65. FDA drug approval: application review times largely reflect agency goals : report to Congressional requesters

Publication:: Washington, DC : United States Government Accountability Office, March 2020
Subject(s):: Investigational New Drug Application -- organization & administration
Time Factors
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

66. Orthopedic non-spinal metallic bone screws and washers: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020
Subject(s):: Bone Screws
Equipment Safety
Orthopedic Equipment
Orthopedic Fixation Devices
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

67. Magnetic resonance (MR) receive-only coil: performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020
Subject(s):: Equipment Safety
Magnetic Resonance Imaging
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

68. Best practices in developing proprietary names for human prescription drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Drug Labeling
Medication Errors -- prevention & control
Prescription Drugs
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

69. Requesting FDA feedback on combination products: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020
Subject(s):: Biological Products
Formative Feedback
Legislation, Drug
Medical Device Legislation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

70. Science and tech spotlight: COVID-19 testing

Publication:: [Washington, DC] : United States Government Accountability Office, May 2020
Subject(s):: COVID-19 Testing -- methods
United States
United States. Food and Drug Administration

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