FDA's Draft Guidance on LDT Regulation Released In Full, Plus Guidance on Notification

by John Audette | Sep 30, 2014 | LDT Regulation, News, Regulation

The FDA today released the full version of its draft guidance on LDT regulation, and also its draft guidance covering notification and reporting by LDT developers (the previously released copy of the regulatory guidance was titled "Anticipated Details," and was pre-released in response to ...

Video of Congressional Hearing on LDTs Posted Online; FDA Defends Regulatory Authority

by John Audette | Sep 15, 2014 | LDT Regulation, News, Regulation

The video coverage of the September 9 House Energy and Commerce Health Subcommittee hearing regarding the FDA's intention to issue draft guidance on laboratory-developed tests has been posted online at

Congressional Subcommittee Hears Testimony on LDTs

by John Audette | Sep 10, 2014 | LDT Regulation, News, Regulation

Following quickly on the heels of the AACR statement in support of FDA regulation of LDTs, the co-founder of The Coalition for 21st Century Medicine, Kathleen Wilsey, today presented to Congress testimony that includes significant concerns about the potential for negative impacts from FDA ...

AACR Affirms Its Support For FDA Regulation Of High Risk LDTs, But Is There Proof of Harm? Ovasure Doesn't Seem to Provide It.

by John Audette | Sep 09, 2014 | LDT Regulation, News, Regulation

The American Association for Cancer Research has published a policy statement urging the FDA to regulate high risk LDTs. The fact that FDA intends to do so certainly isn't news to anyone who is following the issue, but this is the first such statement that I know of from a medical professional ...

European Medicines Agency Publishes Concept Paper on Biomarker Best Practices

by John Audette | Sep 02, 2014 | Development, News, EMEA

Last month the EMA published a "concept paper" to organize the drafting of a "Guideline on good genomics biomarker practices," and to provide a way for interested parties to provide ideas and feedback on the proposal.




Pharmacovigilance and Safety Biomarkers

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