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FDA Works To Speed The Advent Of New, More Effective Personalized Medicines

As part of an agency-wide initiative to speed development of new medical products through the science of pharmacogenomics, the Food and Drug Administration (FDA) today issued a final guidance titled "Pharmacogenomic Data Submissions."

Pharmacogenomics allows health care providers to identify sources of an individual's profile of drug response and predict the best possible treatment option for this individual. For example, genomic tests are helping to identify cancers that have a good chance of responding to a particular medication or regimen. This technology has enabled the development of targeted therapies like Herceptin for metastatic breast cancer, Gleevec for chronic myeloid leukemia and Erbitux for metastatic colorectal cancer.

"FDA's efforts will bring us one step closer to 'personalizing' medical treatment," explained Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA. "This new technology will allow medicines to be uniquely crafted to maximize their therapeutic benefits and minimize their potential risks for each patient."

Instead of the standard hit-or-miss approach to treating patients, where it can take multiple attempts to find the right drug and the right dose, doctors will eventually be able to analyze a patient's genetic profile and prescribe the best available drug therapy and dose from the start. Both the guidance and a new Web page are part of a broad effort underway at FDA to foster pharmacogenomics during drug development.

FDA also recently approved the first laboratory test, the Amplichip Cytochrome P450 Genotyping Test, which will enable physicians to use genetic information to select the right doses of certain medications for cardiac, psychiatric diseases and cancer.

"We hope ultimately to bring pharmacogenomics, a way in which to foster the personalizing of medicine, to every healthcare professional's prescription pad for the benefit of their patients and U.S. consumers," said Dr. Woodc
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Source:FDA


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