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Policy Updates

House Subcommittee Holds Hearing on FDA’s Proposed LDT Guidance

Among other topics, the U.S. House Energy & Commerce Subcommittee on Health heard stakeholder opinions on whether lab-developed tests (LDTs) are a service or a medical product and whether the FDA’s proposed LDT regulation framework complements the Clinical Laboratory Improvement Amendments (CLIA) on September 9, 2014.
» View Hearing Materials and Video

FDA Issues Final Guidance on In Vitro Companion Diagnostic Devices
The report pertains to devices that are used to guide safe and effective treatment of corresponding therapeutic products.
» Download the Report

FDA Issues Draft Guidance on Expedited Approval for Select Medical Devices
The report pertains to devices that treat life-threatening or irreversibly debilitating illnesses.
» Download the Report


PMC News

PMC Continues Dialogue With Congress at Roundtable Discussion

After PMC submitted a letter to the U.S. House Energy and Commerce Committee on June 1, PMC President Edward Abrahams participated in a personalized medicine roundtable discussion with the Committee on July 23.
» Watch the Discussion

PMC Summarizes Proposed Framework for LDT Regulation
In this blog post, PMC Executive Vice President Amy Miller provides an overview of FDA's proposed framework for LDT regulation.
» Read the Post

PMC Discusses Cost and Value
In this blog post, PMC Executive Vice President Amy Miller examines how to define and assess value in cancer care.
» Read the Post

PMC Provides Expert Analysis on Personalized Medicine Education
Alongside her colleagues, PMC Executive Vice President Amy Miller speculates on what the public needs to know about personalized medicine.
» Explore the Conversation

PMC Engages CMS on APMs
PMC advocates for alternative payment models (APMs) that encourage personalized medicine in this letter to CMS.
» Download the Letter