Food and Drug Administration (FDA)
Scientific Research
This section describes basic and clinical research activities supported or sponsored by the Federal government.
The FDA Center for Drug Evaluation and Research (CDER) is planning to conduct research to assess the impact of different renal function estimating equations for drug-dosing, and to address the question of whether or not Cockcroft-Gault (CG)-based dosing adjustments in current labels should be retained or replaced. Dose adjustments for renally-cleared drugs are frequently based on CG estimates of renal function on the drug label. However, many clinical laboratories are now reporting estimates of renal function using the Modification of Diet in Renal Disease (MDRD) Study equation. Moreover, the movement to standardize the serum creatinine assay measurements has further raised the issue of validity of the renal function estimating equations developed, based on non-standardized assays for drug dosing. FDA will first explore whether or not the MDRD, an estimation of filtration, can adequately predict the level of drug exposure for drugs that are excreted by the kidney as compared with CG.
This and other chronic kidney disease research projects are funded under the Critical Path Initiative and Regulatory Science and Review Enhancement research grant.
Contact Information
Nancy Xu, MD
Medical Officer, Center for Drug Evaluation and Research
Phone: 301–796–4079
Email: nancy.xu@fda.hhs.gov
Web: www.fda.gov/cder
The FDA Center for Devices and Radiologic Health (CDRH) carries out the pre-market and post-market regulation of medical devices for the diagnosis and monitoring of renal disease. These devices include diagnostic devices (e.g. radiologic and other imaging devices; in vitro diagnostic tests; and sensing devices including telemonitoring devices); therapeutic devices (e.g. dialysis, surgical, and nutritional devices); and general hospital devices (e.g. sterilization equipment and bandages).
CDRH also oversees the regulation of combination products such as in vitro diagnostic tests that are intended to select or exclude patients for treatment with a particular drug; therapeutic medical devices that contain a drug that is passively and actively released by the medical device; and imaging materials such as radiocontrast media where the material is regulated as a drug to be used with an imaging medical device.
Contact Information
Max Robinowitz, MD
Medical Officer, Center for Devices and Radiological Health
Phone: 240–276–1300
Email: max.robinowitz@fda.hhs.gov
Web: www.fda.gov/cdrh
This information was reviewed by KICC agency representatives. It may not reflect new or future agency activities. For more information, please contact the listed representatives. |
