Science & Research
FDA CRADAs
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FDA/Center Principal Investigator
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Collaborator(s)
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Title of CRADA
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OC/OCPP Armando Oliva, M.D. |
GlobalSubmit, Inc.
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Study Design Software
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CDER Federico Goodsaid, Ph.D. |
Eli Lilly and Company
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Development of Standards, Data Integration, and Applications for Analyzing and Visualizing Heterogeneous Datasets |
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CDER Joseph Hanig, Ph.D. |
Mosaiques Diagnostics | Identification and Validation for Urinary Biomarkers for Drug Toxicity |
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CDRH Aldo Badano, Ph.D. |
Ginzton Technology Center--Varian Medical Systems, Inc. | X-ray Detector Models for Imaging Breast Cancer |
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CDER Federico Goodsaid, Ph.D. |
Adaptive Pharmacogenomics, LLC, and GlaxoSmithKline R&D |
Development of a General Purpose Software Tool that Optimizes Clinical Study Design with Biomarkers |
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CBER Sanjay Kumar, Ph.D. |
Program for Appropriate Technology in Health |
Bioassays to Predict the Biological Activity, Safety, and Virulence of Live Attenuated Plasmodium Falciparum Sporozoite |
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CDRH V. Michelle Chenault, Ph.D. |
Eyelight Diagnostics, Inc. | Non-Invasive Assessment of Individuals at Risk for Diabetes |
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CBER Raj K. Puri, M.D., Ph.D. |
Protox Therapeutics, Inc. |
Development and Characterization of Novel Protein Toxin Therapeutics Targeting IL-4 Receptor |
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CDER Joga Gobburu, Ph.D. |
American Association of Pharmaceutical Scientists (AAPS) |
Enhancing IND/NDA Review Quality via Quantifying Prior Knowledge |
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CDER |
Ingenuity, Inc. |
Reference Database Exploration Tool for Regulatory Review of Biomarker, Pharacogenomic, and Toxicogenomic Data |
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CDER |
Infrastructures for Information, Inc. (i4i) | FACTS@FDA Label and Listing Collaboration System |
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CDER |
Eli Lilly and Company | An Integrated Approach to Evaluation of Viral Clearance for Monoclonal Antibodies |
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NCTR |
Teijin Pharma, Ltd. | Methods of Development for Determining Pig-A Mutations in Rodents by Flow Cytometry |
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NCTR |
Univ. Arkansas for Medical Sciences | Ketamine Pharmakinetics in Children |
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NCTR |
CIIT Centers for Health Research | ACB-PCR in Dose Response Assessment and Mode-of-Action Evaluation |
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CDER |
Entelos, Inc. | Development of Drug-Induced Liver Injury (DILI) PhysioLab Platform |
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CDRH |
Raydiance, Inc. | Medical Applications of a High Energy Femtosecond Laser |
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CFSAN |
In Vitro Technologies | Cryopreserved Human Hepatocytes to Increase Plateability and Extend Culture Life |
| CFSAN Jonathan Deeds, Ph.D. |
University of Washington |
Development of a Surface Plasmon Resonance-based Biosensor for the Detection of PSP Toxins |
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C FSAN |
Mushroom Council | Diseases Resistance and Vitamin D Rich Edible Mushroom Consumption |
| CFSAN Stacey Etheridge, Ph.D. |
Woods Hole Oceanographic Institution |
Alexandrium Fundyense Distributions in the Gulf of Maine: Shellfish Toxicity, Verical Toxin Flux, and Bloom Dynamics in a Complex Shelf Sea |
| CDRH Ronald Robinson, Ph.D. |
Epicor/St. Jude Medical |
Optical Techniques for the Non-Invasive 3D Characterization of Biomedical Ultrasound Beams |
| CDER Karol Thompson, Ph.D. |
Affymetrix, Inc. |
Toxigenomic Signature Analysis of Drug-Induced Vascular Injury |
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CBER |
Novartis | Env-Gp41 Oligomeric Immunogen |
| NCTR Fred A. Beland, Ph.D. |
BG Medicine |
Systems Toxicology from the 28-day Rat Study for Prediction of Clinical Liver Toxicology Potential |
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CDER |
Pfizer, Inc. | Evaluation of Biomarkers of Drug-Induced Vascular Injury |
| CDRH Aldo Badano, Ph.D. |
FIMI/Phillips, Inc. | High-Dynamic-Range Display of Medical Images |
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CBER |
National Hemophilia Foundation | Genetics of Inhibitor Antibody Response |
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CDER |
ChemImage | Raman Chemical Imaging of Pharmaceutical Solids |
| CDER R. Daniel Benz, Ph.D. |
Lhasa Limited |
Development of FDA Toxicology Databases Suitable for Human Expert Rule Development and Mechanistic Understanding of Chemical-Induced Toxicity |
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CDER/CDRH |
Novartis | Co-Development of Drugs and Pharmacogenomic Tests |
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NCTR |
Boehringer-Ingelheim Pharmaceuticals | Long-term Dopaminergic Receptor Stimulation on Compelx Brain Functions |
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CBER |
U.S. Civilian Research & Development Foundation | Test Kit for Quantitative Genotyping of Subtypes of HCV |
| NCTR Syed Ali, Ph.D. |
University of Arkansas Fayetteville |
Wireless Deep B Stimulation in Non-human Primates with MPTP-Induced Parkinson's Disease |
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CDER |
Pharsight Corporation | Enhancing IND/NDA Study Data Review Process |
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CDER |
U.S. Pharmacopeia | Substance Registration Project |
| CDRH Howard Bassen |
Biophan Laboratories |
Measurement and Computer Modeling to Evaluate the Safety of Medical Implants in the Presence of Electromagnetic Fields from Magnetic Resonance Imaging |
| CDER Helen Winkle |
LightPharma, Inc. |
Understanding manufaturing Science to Caprture Opportunities on the Critical Path for Chemistry, Manufacturing, and Controls (CMC) |
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CBER |
Albert Einstein College of Medicine | Characterization of Novel Live Attenuated TB Vaccine Strains |
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CFSAN and CDER |
Leadscope, Inc. | Development of Toxicology and Clinical Effects Databases |
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CBER |
American Type Culture Collection (ATCC) | Oligonucleotide Microarrays for Identification and Genotyping of Mycoplasma |
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CDER |
Novartis Institutes for Biomedical Research, Novartis, Inc. | Criteria for Drug Evaluation of Genomic Biomarkers of Safety |
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NCTR |
Toxicology Excellence for Rise Assessment (TERA) | Development of a Method to Use In Vivo Mutagenicity Data |
| NCTR Bruce D. Erickson, Ph.D. |
Pfizer, Inc. |
Evaluation of Mechanisms of Inactivation and Degradation of Third Generation Cephalosporins by Bovine Intestinal Microflora |
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NCTR |
University of Maryland | Development of a PBPK/PD Model for Acrylamide |
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CBER |
Meriture, Inc. | Development of Analysis or Peptides for Antiviral Effect on Ebola Virus Infection |
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CDRH |
The Foundation for Research on Information Technologies in Society--IT'IS | Numerical Models and Tools |
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CFSAN |
Cepheid, Inc. | Specific Reagent for the Detection of Norwalk Virus |
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OC/OCIO |
GlobalSubmit, Inc. | Common Table of Contents |
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CDER |
Texas A&M University, Kingsville | Creation of "Design Space" for Novel Targeted Dosage Forms |
| CFSAN Angelo DePaola, Ph.D. |
North Carolina State University |
Ecology and Control of Pathogenic Strains of Vibrio Vulnificus (Vv) and Vibrio Parahaemolyticus (Vp) in U.W. Gulf Coast Oysters |
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NCTR |
University of Illinois | Phytoestrogens and Aging |
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NCTR |
University of Arkansas | Comprehensive Assessment of Motion Sickness and Neurovestibular Disorders |
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CDER |
Novartis, Inc. | Application of PAT Tools During Manufacturing |
| NCTR Merle G. Paule, Ph.D. |
Pfizer, Inc. |
Cognitive Assessments of Certain Psychotropic Compounds Using NCTR Operant Behavioral Test Battery |
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NCTR |
SAS Institute, Inc. | Development of Array Track Modules to Linking Functionality PI Polymer Structure |
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CDER |
Conformia, Inc. | Survey of Pharmaceutical Needs |
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CBER |
Aeras Global TB Vaccine Foundation | Development of Preclinical Assays for Safe Use of TB Vaccines |
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CBER |
Technion Research and Development Foundation | Use of Microarray Technology to Identify New Genes |
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CBER |
University Michigan Medical School | IL-13 Fusion Cytotoxin as a Targeted Therapeutic |
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CDRH Ronald W. Waynant |
NanoSonic, Inc. |
Optical Fiber-Based Instrumentation for Monitoring Breath Biomarkers |
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CDRH William F. Pritchard, M.D., Ph.D. |
Univ. of Pennsylvania |
Biomechanics and Genomics of Vascular Dysfunction and Healing |
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NCTR Z. Binienda, D.V.M., Ph.D.
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Sigma Tau Research, Inc. | Development of Biomarkers for Early Detection of Mitochondrial Dysfunction |
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CBER Ewa Marszal, Ph.D. |
Alpha-1 Foundation | Investigation of Alpha-1-PI Polymer Structure |
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CBER Carl Frasch, Ph.D. |
Program for Appropriate Technology in Heath (PATH) |
High Yield Group A Meningococcal Polysaccharide-Tetanus Toxoid Conjugates |
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CDER Edwin J. Matthews, Ph.D. Joseph F. Contrera, Ph.D. |
MultiCASE
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Enhancement of the Performance of the MultiCASE (Q)SAR Software and FDA Toxicology Prediction Models |
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CDER Kurt Brorson, Ph.D. |
Parenteral Drug Assn. |
Large Virus Filter Nomenclature Standardization |
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CDER Norman Stockbridge, M.D. |
Mortara Instrument |
Design and Development of a Customized ECG Warehouse |
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NCTR Richard D. Beger, Ph.D. |
RxGen, Inc. | Metabonomics of Hepatotoxicity in Humans |
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CBER Raj Puri, M.D., Ph.D. |
NeoPharm, Inc. NIH/NINDS |
Convection-enhanced Delivery of IL13-PE38QQR for Treatment of Diffuse Brainstem Gliomas |
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CFSAN Robert W. Dickey, Ph.D. |
Mote Marine Laboratory |
Toxicity, Trophic Transfer and Persistence of Harmful, Algal Toxins and Metabolites in Shellfish |
| NCTR Dwight Miller, Ph.D. |
Litmus, LLC |
Innovative, Static, and Dynamic Chemical Sensors |
| CBER Jenny Riemenschneider, Ph.D. |
HemaTech, LLC |
Analysis of Anthrax Antibody Production in Conventional and Transchromosomal Cows |
| CBER Carolyn Wilson, Ph.D. |
Scripps Research Institute |
Expression and Function of the Human PERV A Receptor |
| CBER Willie Vann, Ph.D. |
University of Illinois |
Rational Design of Anti-Meningococcal Polysaccharide Conjugate Vaccine |
| CDRH Stephen Hilbert, Ph.D. |
LifeSpan, Inc. |
Explant Pathology Studies of Small Intestinal Submucosa Fabricated Pulmonary and Mitral Valve Replacements Implanted in Sheep |
| CBER Raj K. Puri, M.D., Ph.D. |
American Type Culture Collection (ATCC) |
Analysis of Gene Expression by Microarray on Various Cell Lines |
| CBER Raj K. Puri, M.D., Ph.D. |
Holland Laboratory, American Red Cross |
Transgenic Mouse Model for the Study of Variant Creutzfeldt-Jakob Disease |
| CDER Robbe Lyon, Ph.D. |
Pfizer, Inc. |
Assessment of On-line or At-line Vibrational Spectroscopy and Chemical Imaging Techniques in Pharmaceutical Manufacturing for Controlling Critical Quality Attributes |
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CDER |
MDL, Inc. | Development of Toxicology Prediction Modeling Modules |
| CDER Randy Levin, M.D. |
IBM |
Development of a Physical Database for Study Data for Clinical and Non-Clinical Data at FDA |
| CBER Konstantin M. Chumakov, Ph.D. |
Johns Hopkins University |
Development of Biochip-Based Technologies for Detection of Pathogenic Bacteria and Viral Agents and Establishment of a Secure Central Repository for Microarray Data |
| CBER Margaret C. Bash, M.D., M.P.H. |
Research Triangle Institute |
Porin Gene Variable Region Typing of Neisseria gonorrhoeae |
| CVM David G. White, Ph.D. |
University of Maryland |
Characterization of Multiple Antibiotic Resistance Among Enterohemorrhagic E. coli |
| CDRH Brian Beard |
Mobile Manufacturers Forum |
Medical Device Electromagnetic Interference (EMI) from Wireless Data Devices and Interlaboratory Comparison of Radiofrequency (RF) Dosimetry Data from Handheld Transmitters |
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CDER |
Lincoln Technologies |
Advanced Analytical Tools for Drug Safety Risk Assessment |
| CFSAN Keith Lampel, Ph.D. |
Whatman Bioscience |
Universal Method for the Preparation of PCR Template of Pathogenic Microorganism Using FTA Filters |
| CDER Frank Sistare, Ph.D. |
OxfordGlycoSciences, Inc. |
Development of Improved Biomarkers for Early Detection of Mycocardial Injury, Vascular Injury,and Liver Injury |
| CDER Randy Levin, M.D. |
DataPharm Foundation |
Electronic Collection, Processing and Distribution of Drug Product Infomation |
| CVM David G. White, Ph.D. |
University of Georgia Research Foundation | Salmonella through Food Chain, a Molecular Approach |
| CDER Randy Levin, M.D. |
Lincoln Technologies, Inc. |
Design and Development of a Prototype Integrated Submissions Data Repository and Data Validation and Transformation Tool for eSubmission CRT Data |
| CDER Frank Sistare, Ph.D. |
Schering Plough |
Identification and Evaluation of Vasculitis Induced by SCH351591 |
| CDER Randy Levin, M.D. |
PharmQuest, Inc. |
Development of Carcinogenicity and Toxicology Data Management System |
| CBER Emmanuel Petricoin, Ph.D. |
NIH/National Cancer Institute and Correlogic Systems, Inc. |
Use of Pattern Discovery Technology to Identify Patterns of Protein Expression Associated with Specific Disease States |
| CDER Randy Levin, M.D. |
PPD Informatics/PPD Development, Inc. |
Automation of Patient Profiles for Use with Submission Data Interface and Automated Import Screening |
| CVM Robert D. Walker, Ph.D. |
Clinical Microbiology Institute (CMI) |
In Vitro Antimicrobial Testing of Clinically Important Antimicrobial Agents |
| CBER Serge Beaucage, Ph.D. |
Agilent Technologies, Inc. |
Synthesis of Oligonucleotides on Planar Glass Surfaces |
| NCTR Merle Paule, Ph.D. |
University of Arkansas Little Rock |
Effects of Prenatal Cocaine on Behavioral Plasticity |
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CVM |
Riviere Consulting, Inc. | Quality of Animal Drug Submissions |
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CDER, CBER, CVM |
Pharsight Corp. | Enhanced Clinical Drug Trial Simulation and Population PK Analysis Software |
| CBER Dennis Klinman, M.D., Ph.D. |
Coley Pharmaceuticals Group, Inc. |
CpG Oligonucleotides Optimized for Activity in Humans |
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CVM |
U.S. Poultry and Egg Association |
Fluoroquinolone Resistance Among Pathogenic Avian Escherchia coli |
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NCTR |
University of Arizona Arizona Cancer Center |
Dietary Isothiocyanates, Glutathione S-transferases, and Colorectal Neoplasia |
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CDER |
U.S. Pharmacopeia (USP) |
Collaboration Regarding USP Reference Standards |
| CDRH Russell D. Owen |
Cellular Telecommunications Industry Assn. (CTIA) |
Health Effects of RF Emissions from Wireless Phones |
| NCTR Paul Howard, Ph.D. |
Argus Research Labs, Primedica Corporation | Skin Tumorigenesis in SKH-1 Mice |
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CDER |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Immune Biomarkers for Monitoring Drug-Induced Vasculitis |
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CDRH |
Program for Appropriate Technology in Health (PATH) |
Effects of Storage, Materials and Stress on Latex Glove Integrity |
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CBER |
Neurocrine Biosciences, Inc. |
A Circular Permuted IL-4 Pseudomona Exotoxin as an Anti-Cancer Agent |
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ORA |
EduNeering, Inc. |
Transitioning FDA Basic Law Course to On-line Learning |
| NCTR Fred Kadlubar, Ph.D. |
Genometrix, Inc. |
Drug and Cancer Susceptibility Gene Analysis Using Microarray DNA Chip Technology |
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CVM |
Conservation Fund, Freshwater Institute | Bacterial Pathogens in Fluidized Sand Biofilters |
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CFSAN |
University of Maryland | FT-NIR Rapid Determination of Food Integrity |
| CDER Frank Sistare, Ph.D. |
Boehringer Ingelheim Pharmaceuticals, Inc. |
Transgenic Mouse Model as a Short-term Alternative to Predicting the Carcinogenecity of Pharmaceuticals |
| CDRH Vesna J. Tomazic-Jezic, Ph.D. |
Safeskin Corporation |
Frequent Use of C Latex Products that may Play a Role in the Rate of Sensitization and the Intensity of Reaction to Latex Products |
| CDRH Paul L. Jones |
Institute of Electrical and CDP Electronics Engineers (IEEE) |
Improvement in the Quality of Software that is Used in Medical Devices to Increase Their Safety and Effectiveness |
| CDER Joseph F. Contrera, Ph.D. Edwin J. Matthews, Ph.D. |
Multi/CASE |
Multi/CASE Software Program Database Modules to Enhance Their Application for Predicting and Characterizing Toxicity of Pharmaceuticals |
| CFSAN Elizabeth Calvey, Ph.D. |
University of Maryland |
Collaboration through Joint Institute of Food Safety and Applied Nutrition (JIFSAN) Regarding Food Safety, Human Nutrition and Animal Health Sciences |
| NCTR Daniel Sheehan, Ph.D. |
Chemical Manufacturers Association |
Development of a Statistically Robust 3D-QSAR Model to Predict In Vitro Rate Uterine Estrogen Receptor Binding Activity |
| OC/OMS Kathryn Huntley, Ph.D. |
BDM Federal, Inc. |
Development of AutoCode CS Software to Facilitate the Processing and Retrieval of Textual Information with Potential Application to Other Fields |
| CBER Raj K. Puri, M.D., Ph.D. |
NeoPharm, Inc. |
Interleukin-13 Pseudomonas Exotoxin as Anticancer Agent |
| NCTR Jon G. Wilkes, Ph.D. |
Scientific Instrument Services, Inc. |
New Technologies for Improving High Performance Liquid Chromatography Detection |
| NCTR Merle G. Paule, Ph.D. |
Astra Charnwood |
Development of Non-Human Primate Model for Studying Consequences of Long Term Anticonvulsant Medication Function in Developing Animals |
| OC/OMS Kathryn Huntley, Ph.D. |
BDM Federal, Inc. |
Development of Autocode 1.0 (Medical Terminology) to Support the Medical Regulatory Products Lifecycle |
| CDRH, CBER & ORA | Diagnostic Products Corporation |
Testing Human Sera for Total IgE and Specific IgE for Detection and Survey of Allergenic Disease |
| NCTR Dr. Julian Leakey |
Gentest Corporation |
Development of Cell Lines Expressing Individual UDP-glucuronosyltransferase Isoforms |
| CFSAN Dr. Daniel Benz |
CRC Press |
Food Additives: Toxicology Regulation and Properties |
| NCTR C.D. Jackson, Ph.D |
Proctor & Gamble |
Hepatoxicity in Induction of Liver Tumors in Mice Treated with Doxylamine, Pyrilamine and Triprolidine |
| CDRH Paul S. Ruggera |
Organ, Inc. |
Rapid and Uniform Heating of Vitrified Organs Under 1000 Atmoshperes of Pressure |
| CDER Raymond Lipicky, Ph.D. |
Medifacts, Inc. | Ambulatory Blood Pressure Monitoring |
| CFSAN Elizabeth Calvey, Ph.D. |
State University of New York |
Use of Supercritical Fluid Technologies in Analysis and Processing of Allium Species |
| NCTR C. Dan Brand |
American Institute for Cancer Research |
Modularity Effects of Caloric Restriction on Toxicological Process |
| CFSAN Karen Carson |
Illinois Institute of Technology |
Collaborative Research in Food Safety and Quality (National Center for Food Safety and Technology) and Individual Project Agreements |
| CBER Dr. James Vickers |
Tulane University |
Development of Non-Human Primate Model for Krebbe's Disease |
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NCTR |
Electric Power Research Institute |
Risk Assessment of Manufactured Gas Plan Residues |
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NCTR |
National Grocery Manufacturers of America |
Effects of Long Term Exposure to Methyl Bromide |
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NCTR |
Best Foods, Inc. |
Carcinogenic Study: The Effects of Dietary Fat, Carbohydrates and Fiber |
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CBER |
SNS, Inc. | Auto On-Line Hydrolysis System |
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NCTR |
Clement Associates |
Evaluation of Animal Bioassay Data Through Use of Computer-Based Statistical Programs |
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NCTR |
D&M Consulting |
Improved Methods/Measurements of Brain Functions in Response to Environmental Stimuli |
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NCTR |
Transgenic Sciences, Inc. |
Research & Development on In Vitro Toxicology Tests |
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NCTR |
G.K. Scientific, Inc. |
Testing and Evaluation of Electrophoresis Funnel Apparatus |