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Breaking Down Barriers Between Pre-clinical and Clinical Adoption of Personalized Medicine

Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align...more

FDA Hits “Pause” on Regulation of LDTs

On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a Discussion Paper on Laboratory Developed Tests (LDTs) (LDTs) (Discussion Paper). The Discussion Paper follows FDA’s late 2016 announcement that,...more

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug...more

2/8/2017  /  Biologics , FDA , Personalized Medicine

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides...more

Capitalizing on Collaboration – The President’s Precision Medicine Initiative

Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its...more

The President’s Precision Medicine Initiative – The First Annual Check-Up

Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective...more

Three Pressing Challenges for Personalized Medicine

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Direct-to-Consumer Genetic Test Authorized by FDA

23andMe is not a traditional diagnostics company. Rather than seeking to directly sell its services to health care professionals, 23andMe went straight to the consumer, offering genetic screening and analysis in a mail-order...more

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

FDA Considering New Regulatory Approaches for NGS – Part II

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

FDA Considering New Regulatory Approaches for NGS – Part I

The Food and Drug Administration (“FDA”) announced a workshop to be held February 20th, 2015, entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to obtain public input regarding...more

FDA Issues Draft Guidance for Regulation of LDTs

On September 30th, 2014 the U.S. Food and Drug Administration published the draft guidance entitled ”Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” (“Guidance”). The publication of the draft Guidance...more

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

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...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

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

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...more

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

7/8/2014  /  CMS , FDA , Healthcare , Personalized Medicine

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...more

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more

11/19/2013  /  FDA , Medical Devices

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary...more

11/19/2013  /  FDA , Medical Devices

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...more

10/30/2013  /  FDA , Healthcare , Personalized Medicine
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