Tag Archives: Companion Diagnostics

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics for Oncology Therapeutic Products

On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA issued … Continue Reading

FDA Publishes Draft Guidance on Investigational IVDs Used in Therapeutic Product Clinical Trials

On December 18, 2017, FDA announced the availability of a new draft guidance, titled “Investigational IVDs Used in Clinical Investigations of Therapeutic Products.”  The draft guidance is intended to inform both product sponsors and IRBs regarding the application of the Investigational Device Exemption (IDE) regulation to investigational in vitro diagnostic devices (IVDs) used in therapeutic … Continue Reading

FDA Releases Final Guidance Concerning In Vitro Companion Diagnostic Devices

On July 31, 2014, the Food and Drug Administration (FDA) released a final guidance entitled “In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff” (the Final Guidance). The Final Guidance explains FDA’s views on development, review, and authorization of in vitro diagnostic (IVD) devices that provide essential information for the … Continue Reading

FDA Releases Report on Agency’s Role in Development of Personalized Medicine Products

On October 29, FDA released a report entitled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development.” As discussed previously on this blog, personalized medicine is a regulatory area that an FDA official has described as “chaotic” and that has ranked among the Center for Devices and Radiological … Continue Reading

Lab Association Petition Challenges FDA’s Authority To Regulate LDTs Under the FDCA

The American Clinical Laboratory Association (ACLA) filed a citizen petition on June 4 challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) as “devices” under the Federal Food, Drug, and Cosmetic Act (FDCA).  ACLA’s petition requests that FDA refrain from promulgating any draft or final guidance or rule purporting to regulate … Continue Reading

Challenging Issues Confronting CoDx Transactions – Part 3 (Regulatory Strategy)

This is the third entry in our series on Challenging Issues Confronting Companion Diagnostics Transactions. The first entry (Introduction) is available here and the second entry (Financial Structures) is available here.  Regulatory Strategy One of the challenges facing pharmaceutical companies and diagnostics companies in companion diagnostic transactions is determining the appropriate contractual framework for executing on … Continue Reading

Challenging Issues Confronting Companion Diagnostics Transactions — Part 2

This is the second entry in our series on Challenging Issues Confronting Companion Diagnostics Transactions. The first entry is available here. Financial Structures in Companion Diagnostics Transactions Pharmaceutical companies and companion diagnostics companies traditionally have very distinct business models, which can pose a challenge when it comes to aligning on the financial components of a development … Continue Reading

Challenging Issues Confronting Companion Diagnostics Transactions – Part 1

Overview The market for companion diagnostics has been growing steadily for a number of years, with some sources estimating that global companion diagnostics market will reach $19.3 billion by 2023.  There are a handful of companies that are major players in both the pharmaceutical and companion diagnostics spaces, as well as a number of smaller … Continue Reading

Regulatory Developments on the Horizon for Personalized Medicine

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at FDA, recently described the regulatory environment for personalized medicine as “chaotic,” noting the need for FDA to provide better clarity on many issues.  Indeed, a strategic priority for the Center for Devices and Radiological Health (“CDRH”) in 2013 is to further … Continue Reading