-
1
-
-
84879460316
-
-
Advancing Regulatory Science at FDA: A Strategic Plan
-
Advancing Regulatory Science at FDA: A Strategic Plan; http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf.
-
-
-
-
2
-
-
84879463640
-
-
National Bioeconomy Blueprint
-
National Bioeconomy Blueprint; http://www.whitehouse.gov/sites/default/files/microsites/ostp/national_bioeconomy_blueprint_april_2012.pdf.
-
-
-
-
3
-
-
84879460106
-
-
What does FDA do? FDA is responsible for protecting the public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off radiation; advancing the public health by helping to speed product innovations; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health
-
What does FDA do? FDA is responsible for protecting the public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off radiation; advancing the public health by helping to speed product innovations; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health; http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm.
-
-
-
-
4
-
-
84859950790
-
FDA's Approach to regulation of products of nanotechnology
-
Hamburg M. FDA's Approach to regulation of products of nanotechnology. Science 2012, 20:299-300.
-
(2012)
Science
, vol.20
, pp. 299-300
-
-
Hamburg, M.1
-
5
-
-
84879461234
-
-
Memorandum for the Heads of Executive Departments and Agencies: Principles for Regulation and Oversight of Emerging Technologies
-
Memorandum for the Heads of Executive Departments and Agencies: Principles for Regulation and Oversight of Emerging Technologies; http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-Emerging-Technologies-new.pdf.
-
-
-
-
6
-
-
84879463287
-
-
FDA Science and Mission at Risk Report
-
FDA Science and Mission at Risk Report; http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf.
-
-
-
-
7
-
-
84879459879
-
-
FDA's Regulatory Science Program in Nanotechnology
-
FDA's Regulatory Science Program in Nanotechnology; http://www.fda.gov/downloads/AdvisoryCommittees/CommittesMeetingMaterials/ScienceBoardtotheFoodandDrugAdmininstration/UCM322212.pdf.
-
-
-
-
8
-
-
84882610553
-
-
Elsevier
-
Lee M.H., Whittlesey K.J., Dang J.M., Colehour M., Arcidiacono J., Lazarus E., et al. Overview of the FDA regulatory process. Stem cell handbook 2013, Elsevier.
-
(2013)
Overview of the FDA regulatory process. Stem cell handbook
-
-
Lee, M.H.1
Whittlesey, K.J.2
Dang, J.M.3
Colehour, M.4
Arcidiacono, J.5
Lazarus, E.6
-
9
-
-
84879464690
-
-
U.S. Food and Drug Administration, Office of the Commissioner, Multi-Center Fellowship in Regenerative Medicine
-
U.S. Food and Drug Administration, Office of the Commissioner, Multi-Center Fellowship in Regenerative Medicine http://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/CommissionersFellowshipProgram/ucm116228.htm.
-
-
-
-
10
-
-
84879460770
-
-
FDA Track; and FDA Publications Database
-
FDA Track; and FDA Publications Database; http://www.accessdata.fda.gov/scripts/publications/.
-
-
-
-
11
-
-
84879459940
-
-
FY 2011 OCP (Office of Combination Products) Performance Report
-
FY 2011 OCP (Office of Combination Products) Performance Report; http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/PerformanceReports/CombinationProducts/ucm317884.
-
-
-
-
12
-
-
33748491517
-
The MicroArray Quality control (MAQC) Project shows inter- and intraplatform reproducibility of gene expression measurements
-
The MAQC Consortium
-
The MAQC Consortium The MicroArray Quality control (MAQC) Project shows inter- and intraplatform reproducibility of gene expression measurements. Nat Biotechnol 2006, 24:1151-1161.
-
(2006)
Nat Biotechnol
, vol.24
, pp. 1151-1161
-
-
-
13
-
-
84879460787
-
-
FDA Genomics
-
FDA Genomics; http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/default.htm.
-
-
-
-
14
-
-
84879462385
-
-
FDA Nanotechnology Home Page.
-
FDA Nanotechnology Home Page; http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm.
-
-
-
-
15
-
-
84879463034
-
-
OCTGT Learn
-
OCTGT Learn; http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.
-
-
-
-
16
-
-
84879461199
-
-
Scientific Professional Development at FDA
-
Scientific Professional Development at FDA; http://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm317397.
-
-
-
-
17
-
-
84879463765
-
-
Announcement of the Health Research Alliance Joint Partnership New Frontiers in Science Distinguished Lectureship Program;
-
Announcement of the Health Research Alliance Joint Partnership New Frontiers in Science Distinguished Lectureship Program; http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/UCM322076.pdfhttp://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm323538.
-
-
-
-
18
-
-
84879462136
-
-
Centers of Excellence in Regulatory Science and Innovation (CERSI)
-
Centers of Excellence in Regulatory Science and Innovation (CERSI); http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm301667.htm.
-
-
-
-
19
-
-
84879461945
-
-
University of Maryland, CERSI Education
-
University of Maryland, CERSI Education; http://www.cersi.umd.edu/education.
-
-
-
-
20
-
-
84879462207
-
-
Ultra-high Throughput Sequencing and Genomics in CDRH
-
Ultra-high Throughput Sequencing and Genomics in CDRH; http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/UCM302634.pdf.
-
-
-
-
21
-
-
77951112851
-
Lack of significant dermal penetration of titanium dioxide from sunscreen formulations containing nano- and submicron-size TiO2 particles
-
Sadrieh N., Wokovich A.M., Gopee N.V., Zheng J., Haines D., Parmiter D., et al. Lack of significant dermal penetration of titanium dioxide from sunscreen formulations containing nano- and submicron-size TiO2 particles. Toxicol Sci. 2010, 115:156-166.
-
(2010)
Toxicol Sci.
, vol.115
, pp. 156-166
-
-
Sadrieh, N.1
Wokovich, A.M.2
Gopee, N.V.3
Zheng, J.4
Haines, D.5
Parmiter, D.6
-
22
-
-
84879462594
-
-
Supporting the Development of Mesenchymal Stem Cells as Medical Therapies" on CBER's innovation and Regulatory Science Web page
-
Supporting the Development of Mesenchymal Stem Cells as Medical Therapies" on CBER's innovation and Regulatory Science Web page; http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/ucm319678.htm.
-
-
-
-
23
-
-
84868010082
-
Quantitative approaches to detect donor and passage differences in adipogenic potential and clonogenicity in human bone marrow-derived mesenchymal stem cells
-
Lo Surdo J., Bauer S.R. Quantitative approaches to detect donor and passage differences in adipogenic potential and clonogenicity in human bone marrow-derived mesenchymal stem cells. Tissue Eng 2012, 18:877-889.
-
(2012)
Tissue Eng
, vol.18
, pp. 877-889
-
-
Lo Surdo, J.1
Bauer, S.R.2
-
24
-
-
84870720871
-
Improved proteomic profiling of the cell surface of culture-expanded human bone marrow multipotent stromal cells
-
Mindaye T., Ra M., Lo Surdo J., Bauer S.R., Alterman M.A. Improved proteomic profiling of the cell surface of culture-expanded human bone marrow multipotent stromal cells. J Proteomics 2013, 78:1-14.
-
(2013)
J Proteomics
, vol.78
, pp. 1-14
-
-
Mindaye, T.1
Ra, M.2
Lo Surdo, J.3
Bauer, S.R.4
Alterman, M.A.5
-
25
-
-
84879460717
-
-
Emerging Technology Embraces the Future (See Section on Robotics)
-
Emerging Technology Embraces the Future (See Section on Robotics); http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm317766.
-
-
-
-
26
-
-
84879460033
-
-
Emerging Technology Embraces the Future (See Section on Phantom Models)
-
Emerging Technology Embraces the Future (See Section on Phantom Models); http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm317766.
-
-
-
-
27
-
-
84879462045
-
-
For Consumers: Emerging Technology Embraces the Future
-
For Consumers: Emerging Technology Embraces the Future; http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm317766.htm.
-
-
-
-
28
-
-
84879463888
-
-
Advisory Committees Home page
-
Advisory Committees Home page; http://www.fda.gov/AdvisoryCommittees/default.htm.
-
-
-
-
29
-
-
84879464322
-
-
Advisory Committees, Committees & Meeting Materials
-
Advisory Committees, Committees & Meeting Materials; http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm.
-
-
-
-
30
-
-
84879459426
-
-
Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity: Report from the Public Meeting (June 23, 2011)
-
Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity: Report from the Public Meeting (June 23, 2011); http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm284442.htm.
-
-
-
-
31
-
-
84879460591
-
-
Public Meeting - Advancing Regulatory Science for Highly Multiplexed Microbiology/MCM Devices, October 13, 2011
-
Public Meeting - Advancing Regulatory Science for Highly Multiplexed Microbiology/MCM Devices, October 13, 2011; http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm267410htm.
-
-
-
-
32
-
-
84879459376
-
-
Public Meeting - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices, September 27-28, 2012
-
Public Meeting - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices, September 27-28, 2012; http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm308079.htm.
-
-
-
-
33
-
-
84879461575
-
-
Voluntary Exploratory Data Submissions (VXDS)
-
Voluntary Exploratory Data Submissions (VXDS); http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ucm083673.htm.
-
-
-
-
34
-
-
77953158485
-
Voluntary exploratory data submissions to the US FDA and the EMA: Experience and impact
-
Goodsaid F.M., Amur S., Aubrecht J., Burczynski M.E., Carl K., Catalano J., et al. Voluntary exploratory data submissions to the US FDA and the EMA: Experience and impact. Nat Rev Drug Discov 2010, 9:435-445.
-
(2010)
Nat Rev Drug Discov
, vol.9
, pp. 435-445
-
-
Goodsaid, F.M.1
Amur, S.2
Aubrecht, J.3
Burczynski, M.E.4
Carl, K.5
Catalano, J.6
-
35
-
-
84879464227
-
-
Number of voluntary exploratory data submissions (VXDS) and biomarker qualification reviews completed per month.
-
Number of voluntary exploratory data submissions (VXDS) and biomarker qualification reviews completed per month. http://www.accessdata.fda.gov/FDATrack/track?program=cder&id=CDER-OCP-VXDS-Reviews-Completed.
-
-
-
-
36
-
-
84879460669
-
-
About FDA: Network of Experts
-
About FDA: Network of Experts; http://www.fda.gov/AboutFDA/CenterOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm289534.htm.
-
-
-
|