Category Archives: FDA

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FDA Approves Companion Dx for PD-1 Inhibitor

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung cancers and 85 % of those are non-small cell lung cancers (NSCLCs).… Continue reading this entry

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air.  Learn what you need to know quickly with these seven questions and answers. What do I Need to Know?… Continue reading this entry

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, contrary to the Agency’s earlier reports, it would not issue a final guidance on its proposed oversight of LDTs to allow “for further … Continue reading this entry

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 Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry

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 insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and … Continue reading this entry

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases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 information on one or at most, several variants at a time. Advances in DNA sequencing technology, notably Next Generation Sequencing (NGS), permit the analysis of millions of variants … Continue reading this entry

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 progress and future direction. The President also announced a series of awards, funded by the National Institutes of Health (“NIH”), to build the infrastructure … Continue reading this entry

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 consider if their diagnostic test may be subject to FDA oversight, either as a moderate risk (Class II) or high-risk (Class III) … Continue reading this entry

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 its regulation of next generation sequencing (“NGS”). Specifically, the agency seeks public comment and feedback on the issues and questions raised in its discussion … Continue reading this entry

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 its regulation of next generation sequencing (“NGS”). Specifically, the agency seeks public comment and feedback on the issues and questions raised in its discussion … Continue reading this entry

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 is the next step in FDA’s implementation of its risk based approach to oversight of LDTs. In addition to noting FDA’s intention for bringing under … Continue reading this entry

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 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

Considering Sex-Specific Variation for Personalized Medicine

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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 particular cancer therapy. In some instances, the prediction of clinical outcome is related not only to the genetic variance … 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

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 understanding and adoption of personalized medicine concepts, services and products, is a key driving force to removing roadblocks to the adoption of personalized medicine. Consistent … Continue reading this entry

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 IVDs are diagnostic tests developed and manufactured by device manufacturers. In the United States, IVDs are regulated by … Continue reading this entry

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing[1] (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 of the information obtained from NGS is as a companion diagnostic for a therapeutic.[2] A significant reduction in the overall cost to sequence the … Continue reading this entry

Recommendations for NextGen Health IT Infrastructure

Health care information technology (health IT) facilitates the delivery of personalized medicine by providing and supporting the infrastructure for patients, consumers and health care providers to communicate and distribute information. The Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) (collectively, the Office) acknowledge the importance of the … Continue reading this entry

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone that will move the industry in ways that are yet to be realized, or even envisioned – a DNA sequencing super computer (HiSeqX) … Continue reading this entry

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 process for the qualification of medical device development tools (MDDT) used in device development and evaluation programs in the Center for Devices and … 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

Medical Device Industry Responds to FDA’s Overseas Clinical Trial Proposed Rule

Guest Post By Jennifer M. Forde, Nathan A. Beaver and David L. Rosen In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices. The proposed rule would replace the current practice, which does … 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

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