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On Oct. 3, the FDA released documents outlining the agency's risk-based plan for regulating laboratory-developed tests (LDTs) as well as its reporting requirements for LDTs and related adverse events. The documents are subject to a 120-day public comment period. Use the links below to access the agency's latest LDT regulation updates and download the documents.
» Follow LDT regulation updates from the FDA
» Download: Framework for Regulatory Oversight of LDTs
» Download: FDA Notification and Medical Device Reporting for LDTs
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
21st Century Cures Invites Feedback on FDA's LDT Regulation Framework
The white paper invites responses to 11 issue areas as well as suggestions on the role of Congress in addressing these and related questions.
» View the Announcement
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