Science & Research
FDA CRADAs
FDA/Center Principal Investigator
| Collaborator(s)
| Title of CRADA
|
CDRH | Kwikpoint/Gaia LLC | Use of Visual Language in Medical Device Safety Publications |
CFSAN | WTI, Inc. | Development of Procedure for the Disinfection of Raw Fish |
CFSAN | Agilent Technologies, Inc. | Mass Spectroscopy-Based Genotyping: New Tools for Food-Borne Pathogen Surveillance and Outbreak Control |
NCTR | Cellular Dynamics International | Assessment of Human Induced Pluripotent Stem Cell (iPSC)-Derived Hepatocytes as an In Vitro Model for Hepatotoxicity |
CDRH | American Society of Plastic Surgeons (ASPS)/Plastic Surgery Foundation | Breast Implant- Anaplastic Large Cell Lymphoma Registry Collaboration |
CDRH | American Academy of Ophthalmology | Development and Analysis of a Registry for Intraocular Lenses (IOLs) |
NCTR | University of Illinois Urbana-Champaign | Botanical Estrogens: Mechanisms, Dose and Target Tissues |
CDER | Malvern Instruments, Inc. | Morphologically Directed Raman Chemical Microscopy of Pharmaceutical Solids |
CBER | University of Texas Health Science Center at San Antonio | Investigation of the Structure of a1-Proteinase Inhibitor Polymers by Atomic Force Microscopy |
ORA | United States Pharmaceopeia | Collaboration between the United States Pharmacopeia and Office of Regulatory Affairs/Food and Drug Administration |
NCTR | TERA- Toxicology Excellence for Risk Assessment | Development of a method to use in vivo mutagenicity data to address the question as to whether a specific chemical induces cancer via a mutagenic or a non-mutagenic mode-of-action (MOA) |
CBER | The University Court of the University of Edinburgh, Roslin Institute | Experimental Models for the Study of the Pathogenesis of Transmissible Spongiform Encephalopathies |
CDRH | Imricor Medical Systems, Inc. | MR Conditional Device Radiofrequency Safety Assessment Method |
CFSAN Eric Brown, Ph.D. | E.I. du Pont Nemours and Company, DuPont Qualicon | Optimization of Rapid Methods for Sample Collection and Transport, Molecular Capture Methods, and Molecular RAPD Subtyping |
ORA Kai-Shun Chen, Ph.D. | E.I. du Pont Nemours and Company, DuPont Qualicon | Optimization of Real Time PCR Assay for Detection of Shigella spp. for Use with the BAX® Instrument |
CBER Luisa Gregori, Ph.D. | Alliance Biosecure Research Foundation | Infectivity Titrations of Blood Components from Chimpanzees Infected with the Agent of Gerstmann-Sträussler-Scheinker Syndrome in Mice and Comparison of Sensitivity of Mouse Bioassays |
CBER Willie Vann, Ph.D. | PATH Vaccine Solutions | Development of Conjugation Technology for Pneumococcal Conjugate Vaccines |
NCTR Barbara Parsons, Ph.D. | The Hamner Institutes for Health Sciences | Evaluating the Utility of ACB-PCR in Dose-Response Assessment and Mode-of Action Evaluation (Phase II) |
CBER Jakob Reiser, Ph.D. | Muscular Dystrophy Association | Remote Therapeutic Delivery for Spinal Muscular Atrophy |
CBER Indira Hewlett, Ph.D. | Nanosphere, Inc. | Development of a Nano-Particle Influenza Assay |
CDRH Paul Jones | Fraunhofer USA, Inc. - CESE | Software Re-engineering and Forensic Analysis |
CDRH Gerry W. Gray, Ph.D. | Cytel, Inc. | Software for Bayesian Clinical Trials |
OC/OCPP Armando Oliva, M.D. | GlobalSubmit, Inc.
| Study Design Software
|
CDER Federico Goodsaid, Ph.D. | Eli Lilly and Company
|
Development of Standards, Data Integration, and Applications for Analyzing and Visualizing Heterogeneous Datasets |
CDER Joseph Hanig, Ph.D. | Mosaiques Diagnostics | Identification and Validation for Urinary Biomarkers for Drug Toxicity |
CDRH Aldo Badano, Ph.D. | Ginzton Technology Center--Varian Medical Systems, Inc. | X-ray Detector Models for Imaging Breast Cancer |
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 |
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 |
CDRH V. Michelle Chenault, Ph.D. | Eyelight Diagnostics, Inc. | Non-Invasive Assessment of Individuals at Risk for Diabetes |
CBER Raj K. Puri, M.D., Ph.D. | Protox Therapeutics, Inc. |
Development and Characterization of Novel Protein Toxin Therapeutics Targeting IL-4 Receptor |
CDER Joga Gobburu, Ph.D. |
American Association of Pharmaceutical Scientists (AAPS) |
Enhancing IND/NDA Review Quality via Quantifying Prior Knowledge |
CDER | Ingenuity, Inc. |
Reference Database Exploration Tool for Regulatory Review of Biomarker, Pharacogenomic, and Toxicogenomic Data |
CDER | Infrastructures for Information, Inc. (i4i) | FACTS@FDA Label and Listing Collaboration System |
CDER | Eli Lilly and Company | An Integrated Approach to Evaluation of Viral Clearance for Monoclonal Antibodies |
NCTR | Teijin Pharma, Ltd. | Methods of Development for Determining Pig-A Mutations in Rodents by Flow Cytometry |
NCTR | Univ. Arkansas for Medical Sciences | Ketamine Pharmakinetics in Children |
NCTR | CIIT Centers for Health Research | ACB-PCR in Dose Response Assessment and Mode-of-Action Evaluation |
CDER | Entelos, Inc. | Development of Drug-Induced Liver Injury (DILI) PhysioLab Platform |
CDRH | Raydiance, Inc. | Medical Applications of a High Energy Femtosecond Laser |
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 |
CFSAN | 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 Phospholipidosis |
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 |
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 |
CBER | National Hemophilia Foundation | Genetics of Inhibitor Antibody Response |
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 |
CDER/CDRH | Novartis | Co-Development of Drugs and Pharmacogenomic Tests |
NCTR | Boehringer-Ingelheim Pharmaceuticals | Long-term Dopaminergic Receptor Stimulation on Compelx Brain Functions |
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 |
CDER | Pharsight Corporation | Enhancing IND/NDA Study Data Review Process |
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) |
CBER | Albert Einstein College of Medicine | Characterization of Novel Live Attenuated TB Vaccine Strains |
CFSAN and CDER | Leadscope, Inc. | Development of Toxicology and Clinical Effects Databases |
CBER | American Type Culture Collection (ATCC) | Oligonucleotide Microarrays for Identification and Genotyping of Mycoplasma |
CDER | Novartis Institutes for Biomedical Research, Novartis, Inc. | Criteria for Drug Evaluation of Genomic Biomarkers of Safety |
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 |
NCTR | University of Maryland | Development of a PBPK/PD Model for Acrylamide |
CBER | Meriture, Inc. | Development of Analysis or Peptides for Antiviral Effect on Ebola Virus Infection |
CDRH | The Foundation for Research on Information Technologies in Society--IT'IS | Numerical Models and Tools |
CFSAN | Cepheid, Inc. | Specific Reagent for the Detection of Norwalk Virus |
OC/OCIO | GlobalSubmit, Inc. | Common Table of Contents |
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 |
NCTR | University of Illinois | Phytoestrogens and Aging |
NCTR | University of Arkansas | Comprehensive Assessment of Motion Sickness and Neurovestibular Disorders |
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 |
NCTR | SAS Institute, Inc. | Development of Array Track Modules to Linking Functionality PI Polymer Structure |
CDER | Conformia, Inc. | Survey of Pharmaceutical Needs |
CBER | Aeras Global TB Vaccine Foundation | Development of Preclinical Assays for Safe Use of TB Vaccines |
CBER | Technion Research and Development Foundation | Use of Microarray Technology to Identify New Genes |
CBER | University Michigan Medical School | IL-13 Fusion Cytotoxin as a Targeted Therapeutic |
CDRH Ronald W. Waynant |
NanoSonic, Inc. |
Optical Fiber-Based Instrumentation for Monitoring Breath Biomarkers |
CDRH William F. Pritchard, M.D., Ph.D. |
Univ. of Pennsylvania |
Biomechanics and Genomics of Vascular Dysfunction and Healing |
NCTR Z. Binienda, D.V.M., Ph.D.
| Sigma Tau Research, Inc. | Development of Biomarkers for Early Detection of Mitochondrial Dysfunction |
CBER Ewa Marszal, Ph.D. | Alpha-1 Foundation | Investigation of Alpha-1-PI Polymer Structure |
CBER Carl Frasch, Ph.D. |
Program for Appropriate Technology in Heath (PATH) |
High Yield Group A Meningococcal Polysaccharide-Tetanus Toxoid Conjugates |
CDER Edwin J. Matthews, Ph.D. Joseph F. Contrera, Ph.D. |
MultiCASE
|
Enhancement of the Performance of the MultiCASE (Q)SAR Software and FDA Toxicology Prediction Models |
CDER Kurt Brorson, Ph.D. | Parenteral Drug Assn. |
Large Virus Filter Nomenclature Standardization |
CDER Norman Stockbridge, M.D. |
Mortara Instrument |
Design and Development of a Customized ECG Warehouse |
NCTR Richard D. Beger, Ph.D. | RxGen, Inc. | Metabonomics of Hepatotoxicity in Humans |
CBER Raj Puri, M.D., Ph.D. | NeoPharm, Inc. NIH/NINDS |
Convection-enhanced Delivery of IL13-PE38QQR for Treatment of Diffuse Brainstem Gliomas |
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 |
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 |
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 |
CVM | Riviere Consulting, Inc. | Quality of Animal Drug Submissions |
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 |
CVM | U.S. Poultry and Egg Association |
Fluoroquinolone Resistance Among Pathogenic Avian Escherchia coli |
NCTR | University of Arizona Arizona Cancer Center |
Dietary Isothiocyanates, Glutathione S-transferases, and Colorectal Neoplasia |
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 |
CDER | Boehringer Ingelheim Pharmaceuticals, Inc. |
Immune Biomarkers for Monitoring Drug-Induced Vasculitis |
CDRH |
Program for Appropriate Technology in Health (PATH) |
Effects of Storage, Materials and Stress on Latex Glove Integrity |
CBER | Neurocrine Biosciences, Inc. |
A Circular Permuted IL-4 Pseudomona Exotoxin as an Anti-Cancer Agent |
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 |
CVM | Conservation Fund, Freshwater Institute | Bacterial Pathogens in Fluidized Sand Biofilters |
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 |
NCTR | Electric Power Research Institute |
Risk Assessment of Manufactured Gas Plan Residues |
NCTR | National Grocery Manufacturers of America |
Effects of Long Term Exposure to Methyl Bromide |
NCTR | Best Foods, Inc. |
Carcinogenic Study: The Effects of Dietary Fat, Carbohydrates and Fiber |
CBER | SNS, Inc. | Auto On-Line Hydrolysis System |
NCTR | Clement Associates |
Evaluation of Animal Bioassay Data Through Use of Computer-Based Statistical Programs |
NCTR | D&M Consulting |
Improved Methods/Measurements of Brain Functions in Response to Environmental Stimuli |
NCTR | Transgenic Sciences, Inc. |
Research & Development on In Vitro Toxicology Tests |
NCTR | G.K. Scientific, Inc. |
Testing and Evaluation of Electrophoresis Funnel Apparatus |
