Subjects: United States. Department of Health and Human Services / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States. Department of Health and Human Services ✖ Genre Technical Report ✖

21. Formal meetings between FDA and ANDA applicants of complex products under GDUFA

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

22. Regulatory considerations for microneedling products: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 10, 2020
Subject(s):: Medical Device Legislation
Needles -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

23. Enhancing the diversity of clinical trial populations: eligibility criteria, enrollment practices, and trial designs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2020
Subject(s):: Biological Variation, Population
Clinical Trial Protocols as Topic
Clinical Trials as Topic
Population Characteristics
Cultural Diversity
Genetic Variation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

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