Subjects: United States. Food and Drug Administration. / Languages: English - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States. Food and Drug Administration. ✖ Languages English ✖ Publication Year 2020 ✖

81. Peripheral vascular atherectomy devices: premarket notification [510(k)] submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, February 13, 2020
Subject(s):: Atherectomy -- instrumentation
Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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

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

83. Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):: Clinical Laboratory Techniques -- standards
Diagnostic Errors
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

84. Recommendations for dual 510(k) and CLIA waiver by application studies: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020
Subject(s):: Clinical Laboratory Techniques
Device Approval
Reagent Kits, Diagnostic
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

85. Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, March 3, 2020
Subject(s):: Device Approval
Suture Anchors
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

86. The "deemed to be a license" provision of the BPCI Act: questions and answers

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

87. Safety testing of drug metabolites

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Pharmaceutical Preparations -- metabolism
Toxicity Tests
Drug-Related Side Effects and Adverse Reactions
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

88. Q3D(R1) elemental impurities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Drug Contamination -- prevention & control
Quality Control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

89. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020
Subject(s):: Device Approval
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

90. Biological product deviation reporting for blood and plasma establishments

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
Subject(s):: Biological Products
Blood Banks -- standards
Mandatory Reporting
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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