In a speech on Nov 12, 2014 at the 10th annual Personalized Medicine Conference, FDA head Dr. Margaret Hamburg provided some data to help give perspective on how much progress has been made in advancing personalized medicine. The first point she made was that...
There have been some interesting developments over the last few weeks in the ongoing discussion about FDA’s desire to regulate LDTs. Pathologists Still Oppose Regulation At the annual meeting Nov. 12-14 of the Association for Molecular Pathology (AMP) a special...
I finally had a chance to watch the complete Congressional hearing on LDT regulation that took place several weeks ago. Several interesting things came up which I haven’t seen mentioned anywhere else: – The issue of FDA’s authority to regulate LDTs...
The FDA today released the full version of its draft guidance on LDT regulation, and also its draft guidance covering notification and reporting by LDT developers (the previously released copy of the regulatory guidance was titled “Anticipated Details,”...
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of the September 9 House Energy and Commerce Health Subcommittee hearing regarding the FDA’s intention to issue draft guidance on laboratory-developed tests has been posted online t house.gov. Among key discussion points was FDA’s...
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