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

Start Over Subjects United States. Food and Drug Administration ✖

101. 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

102. 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

103. 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

104. 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

105. 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

106. 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

107. 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):: Government Regulation
Medical Device Legislation
Product Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

108. S11 nonclinical safety testing in support of development of pediatric pharmaceuticals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Drug Compounding
Drug Industry
Pediatrics
Pharmaceutical Preparations
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

109. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management: annexes

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

110. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management

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

« Previous
Next »
1
2
…
7
8
9
10
11
12
13
14
15
…
20
21