Personalized Medicine – Food and Drug Administration

Posted: May 23, 2015 at 3:46 am

Given the nature of personalized medicine, the FDA places high priority on helping to ensure that the agency, drug manufacturers, physicians and patients have adequate information about the product and its use. Product labeling and tracking of use in the marketplace are critical to the proper application of personalized medication tools.

Product Labeling

The FDA requires product labeling to be balanced, scientifically accurate and not misleading, and that clear instructions be communicated to healthcare practitioners for drug prescribing and/or administration. Personalized medicines that may only be safe and effective in particular sub-populations, or must be administered in different doses in different sub-populations, must be labeled accordingly. To date, the labeling of more than 100 approved drugs contain information on genomic biomarkers (including gene variants, functional deficiencies, expression changes, chromosomal abnormalities, and others).

Post-market Surveillance

While personalized medicine will likely allow for more focused clinical trials by increasing the proportion of responders in the trial or increasing the average effect size, or both, one implication of dramatically smaller pre-market exposure is a general increase in the importance of and emphasis on post-market monitoring, because relatively rare adverse events, in particular, are unlikely to show up when a drug is being tested in a small population, may arise when a broader population is treated. Post-market surveillance, then, is critical to the success of personalized medicine.

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Personalized Medicine - Food and Drug Administration

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