Category Archives: FDA

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Business Models for Personalized Medicine

Personalized medicine is moving from concept to reality, fueled in part by advances in sequencing technology and data analysis. However, significant business challenges remain that hinder growth and adoption of personalized health care. One such challenge how to is pay for the research and development of new diagnostics and therapies when the target patient population does not … Continue reading this entry

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should … Continue reading this entry

FDA To Issue Final Guidance For In Vitro Companion Diagnostics in Mid-2012

Elizabeth Mansfield, Ph.D., Director of Personalized Medicine, Office of In Vitro Diagnostics, Center for Devices and Radiological Health of the Food and Drug Administration (FDA) announced today at the 2012 Personalized Medicine World Conference that the FDA is targeting the second quarter of 2012 to release the FDA’s Final Guidance for In Vitro Companion Diagnostic … Continue reading this entry

Making The Case for Personalized Medicine

The Personalized Medicine Coalition recently published the third edition of its state of the industry report, The Case for Personalized Medicine (“Report”). While the Coalition acknowledges greater adoption of the principles of personalized medicine by the health care industry and the public; technical, legal, regulatory and payor issues are highlighted for improvement to recognize the industry’s … Continue reading this entry

FDA Reports on Initiatives to Drive Biomedical Innovation

Today, the FDA issued a report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients (“Report”) which outlines proactive initiatives to promote science and innovation to meet today’s and the future’s health care challenges. The Report notes that because of its role as both a regulator and a public health agency facilitating the development of … Continue reading this entry

The Genomics and Personalized Medicine Act: A Look Ahead

Institutional barriers (e.g., limitations on product reimbursement, unclear regulatory requirements and occasional government redundancies) have been faulted for relatively slow progress toward wide spread implementation of personalized medicine. In an effort to improve access to and appropriate utilization of valid, reliable genetic tests and to secure the promise of personalized medicine for all Americans, then-Sen. … Continue reading this entry

FDA Releases Guidance Document Regarding Qualification of Genomic Biomarkers

On August 10, 2011, the Food and Drug Administration (FDA) released a guidance document describing recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers. The guidance document was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use … Continue reading this entry

CDC Issues Requests for Comments to Assess and Implement Public Health Genomics

The Centers for Disease Control and Prevention (“CDC”), located within the federal Department of Health and Human Services (“HHS”) is seeking public comments, data or other information to assess the current research, policy and practice environment in public health genomics. The information is solicited to assist the Office of Public Health Genomics (“OPHG”) of the … Continue reading this entry

FDA "Draft Guidance" for Companion Diagnostic Devices

On July 14, 2011, the FDA issued “Draft Guidance” relating to regulatory approval of in vitro companion diagnostic devices/tests, also called “IVD companion diagnostic devices.” The FDA intends the Guidance to assist those (1) who develop a therapeutic product that depends on the use of such a device/test for the product’s safe and effective use, and (2) … Continue reading this entry

PhRMA CEO Speaks at PMC's Annual State of Personalized Medicine Luncheon

On June 9, 2011, the Personalized Medicine Coalition (PMC) hosted its Seventh Annual State of Personalized Medicine Luncheon in Washington, D.C.  As stated on its website, PMC’s mission “is to build the foundation that underpins the advancement of personalized medicine as a viable solution to the challenges of efficacy, safety and cost.”  This year’s luncheon … Continue reading this entry

Personalized Medicine - Promise, Regulation and Challenges

Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual.  Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease.  In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the … Continue reading this entry