Tag Archives: FDA

FDA's Proposed Oversight of Laboratory Developed Tests - Industry Impact

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The U.S. Food and Drug Administration (FDA) recently announced that the Agency is lifting its enforcement discretion over high-risk laboratory developed tests (LDTs). The FDA’s “LDT Guidance” was reviewed in detail in my prior post of August 4th, 2014. In brief, the LDT Guidance proposes a risk-based, phased-in framework for oversight of LDTs that is … Continue reading this entry

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

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Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that certain tests used by health care professionals that diagnose and treat patients are accurate, consistent and reliable, the U.S. Food and Drug … Continue reading this entry

FDA Reaffirms Commitment to Personalized Medicine

In a report released on October 29, 2013, the U.S. Food and Drug Administration (FDA) announced its continued commitment to advancing personalized medicine. “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development” (“Report”) outlines the FDA’s unique role and responsibilities that it has in helping usher in medical products … Continue reading this entry

FDA’s Plan to Regulate LDTs

Guest Post By David L. Rosen, Nathan A. Beaver and Jennifer M. Forde   In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of … Continue reading this entry

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”). The document is intended to provide guidance for … Continue reading this entry

Personalized Multiplex Test on Market

A multiplex test that can analyze tumors for over 200 genes is now available from Foundation Medicine Inc., the Wall Street Journal reported today. The test will be used by Novartis, Sanofi SA, Johnson & Johnson and Celgene to analyze patients in early-stage clinical trials of new cancer drugs to identify patients most likely to benefit from the drug and to … 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

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

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