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Creative Data Solutions (CDS) is a Vanderbilt Shared Resource and has extensive experience in providing effective and robust solutions to challenges pertaining to research data using modern informatics and bioinformatics approaches.
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Connections to United States Food and Drug Administration are shown below. Double-click or tap a node for more information.
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- Reform of drug regulation--beyond an independent drug-safety board.
Ray WA, Stein CM
(2006) N Engl J Med 354: 194-201 - The breast-implant controversy.
Dupont WD
(1993) N Engl J Med 328: 733; author reply 734 - Biomarker Tests for Molecularly Targeted Therapies--The Key to Unlocking Precision Medicine.
Lyman GH, Moses HL
(2016) N Engl J Med 375: 4-6 - Evaluating drugs after their approval for clinical use.
Ray WA, Griffin MR, Avorn J
(1993) N Engl J Med 329: 2029-32 - Making medicines safer--the need for an independent drug safety board.
Wood AJ, Stein CM, Woosley R
(1998) N Engl J Med 339: 1851-4 - Contraindicated use of cisapride: impact of food and drug administration regulatory action.
Smalley W, Shatin D, Wysowski DK, Gurwitz J, Andrade SE, Goodman M, Chan KA, Platt R, Schech SD, Ray WA
(2000) JAMA 284: 3036-9 - Identifying mechanism-of-action targets for drugs and probes.
Gregori-Puigjané E, Setola V, Hert J, Crews BA, Irwin JJ, Lounkine E, Marnett L, Roth BL, Shoichet BK
(2012) Proc Natl Acad Sci U S A 109: 11178-83 - Analytical validation of protein-based multiplex assays: a workshop report by the NCI-FDA interagency oncology task force on molecular diagnostics.
Rodriguez H, Tezak Z, Mesri M, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Philip R, Ransohoff DF, Skates SJ, Regnier FE, Anderson NL, Mansfield E, Workshop Participants
(2010) Clin Chem 56: 237-43 - Protein-based multiplex assays: mock presubmissions to the US Food and Drug Administration.
Regnier FE, Skates SJ, Mesri M, Rodriguez H, Tezak Z, Kondratovich MV, Alterman MA, Levin JD, Roscoe D, Reilly E, Callaghan J, Kelm K, Brown D, Philip R, Carr SA, Liebler DC, Fisher SJ, Tempst P, Hiltke T, Kessler LG, Kinsinger CR, Ransohoff DF, Mansfield E, Anderson NL
(2010) Clin Chem 56: 165-71 - Defining Regional Differences in Drug-Induced Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Tool to Improve Drug Safety?
Phillips EJ
(2019) Clin Pharmacol Ther 105: 22-25 - Are herbal products dietary supplements or drugs? An important question for public safety.
Stein CM
(2002) Clin Pharmacol Ther 71: 411-3 - Detecting drug interactions from adverse-event reports: interaction between paroxetine and pravastatin increases blood glucose levels.
Tatonetti NP, Denny JC, Murphy SN, Fernald GH, Krishnan G, Castro V, Yue P, Tsao PS, Tsau PS, Kohane I, Roden DM, Altman RB
(2011) Clin Pharmacol Ther 90: 133-42 - Patient-reported outcomes in clinical trials of CKD-related therapies: report of a symposium sponsored by the national kidney foundation and the U.S. Food and Drug Administration.
Perrone RD, Coons SJ, Cavanaugh K, Finkelstein F, Meyer KB
(2013) Am J Kidney Dis 62: 1046-57 - Adverse drug reactions and the elderly.
Ray WA, Griffin MR, Shorr RI
(1990) Health Aff (Millwood) 9: 114-22 - Molecule of the month. FDA approves new treatment for fibromyalgia.
Lindsley CW
(2009) Curr Top Med Chem 9: 225 - Molecule of the month. The 'skinny' on CB1 antagonists/inverse agonists: controversial obesity drugs will not go to FDA for approval.
Lindsley CW
(2008) Curr Top Med Chem 8: 1553 - Tumor necrosis factor (TNF) blockers ignite FDA inquiry over cancer concerns.
Lindsley CW
(2008) Curr Top Med Chem 8: 1158 - An informatics-based tool to assist researchers in initiating research at an academic medical center: Vanderbilt Customized Action Plan.
Pulley JM, Harris PA, Yarbrough T, Swafford J, Edwards T, Bernard GR
(2010) Acad Med 85: 164-8 - Clinical and regulatory implications of the Cardiac Arrhythmia Suppression Trial.
Pratt CM, Brater DC, Harrell FE, Kowey PR, Leier CV, Lowenthal DT, Messerli F, Packer M, Pritchett EL, Ruskin JN
(1990) Am J Cardiol 65: 103-5 - Safety evaluation of substituted thiophenes used as flavoring ingredients.
Cohen SM, Fukushima S, Gooderham NJ, Guengerich FP, Hecht SS, Rietjens IM, Smith RL, Bastaki M, Harman CL, McGowen MM, Valerio LG, Taylor SV
(2017) Food Chem Toxicol 99: 40-59 - FEMA GRAS assessment of natural flavor complexes: Mint, buchu, dill and caraway derived flavoring ingredients.
Cohen SM, Eisenbrand G, Fukushima S, Gooderham NJ, Guengerich FP, Hecht SS, Rietjens IMCM, Bastaki M, Davidsen JM, Harman CL, McGowen MM, Taylor SV
(2020) Food Chem Toxicol 135: 110870 - Study design for a comprehensive assessment of biologic safety using multiple healthcare data systems.
Herrinton LJ, Curtis JR, Chen L, Liu L, Delzell E, Lewis JD, Solomon DH, Griffin MR, Ouellet-Hellstom R, Beukelman T, Grijalva CG, Haynes K, Kuriya B, Lii J, Mitchel E, Patkar N, Rassen J, Winthrop KL, Nourjah P, Saag KG
(2011) Pharmacoepidemiol Drug Saf 20: 1199-209 - Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in medicare beneficiaries.
Reynolds WS, Gold KP, Ni S, Kaufman MR, Dmochowski RR, Penson DF
(2013) Neurourol Urodyn 32: 330-5 - Analysis of techniques to secure the renal hilum during laparoscopic donor nephrectomy: review of the FDA database.
Hsi RS, Ojogho ON, Baldwin DD
(2009) Urology 74: 142-7 - Mechanisms of hemostatic failure during laparoscopic nephrectomy: review of Food and Drug Administration database.
Hsi RS, Saint-Elie DT, Zimmerman GJ, Baldwin DD
(2007) Urology 70: 888-92 - The effect of regulatory advisories on maternal antidepressant prescribing, 1995-2007: an interrupted time series study of 228,876 pregnancies.
Bobo WV, Epstein RA, Hayes RM, Shelton RC, Hartert TV, Mitchel E, Horner J, Wu P
(2014) Arch Womens Ment Health 17: 17-26 - Final report of the safety assessment of Kojic acid as used in cosmetics.
Burnett CL, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks JG, Shank RC, Slaga TJ, Snyder PW, Andersen FA
(2010) Int J Toxicol 29: 244S-73
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