Department of Health and Human Services November 1, 2006 – Federal Register Recent Federal Regulation Documents

Advances in medicine, biomedical science, and technology present opportunities for enabling health care practices to be increasingly patient-specific by taking into account individual differences in health states, disease processes, and outcomes from interventions. Often referred to as personalized health care, the desired impact of these types of health practices is improved effectiveness and safety of medical practices. These health benefits may be manifested through new approaches for predicting disease risk at an early time point, enabling preemption of disease processes prior to full manifestation of symptoms, analyzing the effectiveness of different interventions in specific populations based on their genetic makeup, and preventing the progression of disease and the related complications. For the purpose of achieving a broader understanding of rapid changes occurring in the health care setting that may have an impact on the future of personalized health care, the Department of Health and Human Services (HHS) requests input from the public and private sectors on plans for developing and using resources involving health information technology (IT) and genetic and molecular medicine, with specific reference to incorporating these capacities in evidence-based clinical practice, health outcomes evaluations, and research.

The Food and Drug Administration (FDA) is announcing a public workshop on issues related to the application process for seeking approval for marketed unapproved drugs. This will be a 1-day workshop involving FDA staff and representatives from businesses currently marketing unapproved drugs. The purpose of the workshop is to provide clarification and direction to businesses on how to seek approval to legally market drugs through the new drug application (NDA) and abbreviated new drug application (ANDA) processes and how to legally market drugs through compliance with the over-the-counter (OTC) monographs.