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

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111. Providing regulatory submissions in electronic format: standardized study data

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Data Management
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

112. Product identifiers under the Drug Supply Chain Security Act: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Drug Industry
Drug Labeling
Government Regulation
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

113. Drug Supply Chain Security Act implementation: identification of suspect product and notification

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Drug Industry
Drug and Narcotic Control
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

114. Emergency Use Authorization for vaccines to prevent COVID-19

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, May 25, 2021
Subject(s):: COVID-19 Vaccines
Government Regulation
Vaccine Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

115. Bispecific antibody development programs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Antibodies, Bispecific
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

116. Enforcement policy regarding use of National Health Related Item Code and National Drug Code numbers on device labels and packages: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, May 21, 2021
Subject(s):: Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

117. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

118. Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):: Device Approval
Equipment Safety
Magnetic Resonance Imaging -- instrumentation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

119. 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, May 20, 2021
Subject(s):: Atherectomy -- instrumentation
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

120. Implanted brain-computer interface (BCI) devices for patients with paralysis or amputation: non-clinical testing and clinical considerations : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, May 20, 2021
Subject(s):: Amputation
Brain-Computer Interfaces
Equipment Design
Equipment Safety
Paralysis
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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