Personalized Medicine Bulletin The source for business, legal, and regulatory developments shaping an evolving industry

Category Archives: FDA Guidelines

Business Models for Personalized Medicine

Posted by Antoinette Konski on Posted in Economics of Innovation; FDA; FDA Guidelines; Genetic Testing; Personalized Medicine; Reimbursement

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 fit the traditional pharma “block buster” model. Thus, the health care industry is searching for viable business models to fund personalized therapies and companion diagnostics. How does one attract investment? How does one navigate the regulatory pathway? Will payors reimburse the diagnostic? How does one price the product and service?

The Personalized Medicine Business Summit will tackle these issues on May 14th, in San Francisco. Industry heavyweights such as Steve Burrill, Dr. Elizabeth Mansfield of FDA and Ronnie Andrews of Life Technologies will share their experience and insights on evolving business models for personalized medicine.  Further information is provided at www.personalizedmedicinesummit.com.

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

Posted by Antoinette Konski on Posted in FDA Guidelines

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guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”).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 enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics licensed applications (BLAs). Continue reading this entry

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

Posted by Antoinette Konski on Posted in Companion Diagnostics; FDA; FDA Guidelines

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 Devices. The FDA issued its Draft Guidance for In Vitro Diagnostic Devices on July 14th, 2011.  A summary of the FDA’s Draft Guidance is provided in our July 17th, 2011 post.  Thirty-three comments on the Draft Guidance were received in response to the FDA’s invitation for comments and suggestions. All public comments are available for viewing at www.regulations.gov, docket ID: FDA 2011-D-0215. The commentators represented pharmaceutical companies, diagnostic companies, trade organizations, interested individuals and patient advocacy groups.  

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FDA Releases Guidance Document Regarding Qualification of Genomic Biomarkers

Posted by Antoinette Konski on Posted in Biomarkers; FDA; FDA Guidelines

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 (ICH). The guidance is provided to facilitate a consistent format for the submission of data to the end of easy review and exchange of assessments.

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FDA “Draft Guidance” for Companion Diagnostic Devices

Posted by Jackie Wright Bonilla on Posted in Companion Diagnostics; Diagnostic Methods; FDA; FDA Guidelines

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) who develop a companion diagnostic device intended for use with a corresponding therapeutic product.  The FDA invites comments and suggestions regarding the Draft Guidance within 60 days. 

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