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Clinical Chemistry Podcast

This free monthly podcast is offered by Clinical Chemistry. Clinical Chemistry is the leading forum for peer-reviewed, original research on innovative practices in today's clinical laboratory.

FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?

Jul 30, 2013

The US Food and Drug Administration has long maintained its right to regulate LDTs; however until recently they've chosen to exercise discretion and have left this to the individual laboratories and other regulatory agencies. This is now in a state of change, and the FDA has stated that it would issue guidance on its...


Jul 30, 2013

The US Food and Drug Administration has long maintained its right to regulate LDTs; however until recently they've chosen to exercise discretion and have left this to the individual laboratories and other regulatory agencies. This is now in a state of change, and the FDA has stated that it would issue guidance on its...


FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?

Jul 30, 2013

The US Food and Drug Administration has long maintained its right to regulate LDTs; however until recently they've chosen to exercise discretion and have left this to the individual laboratories and other regulatory agencies. This is now in a state of change, and the FDA has stated that it would issue guidance on its...


Jul 22, 2013

Prenatal development involves a series of highly-organized genetic and epigenetic events. Abnormalities in the epigenetic control of developmental processes have been implicated in infertility, spontaneous abortion, intra-uterine growth abnormalities, and numerous post-natal consequences.


Jul 15, 2013

Human growth hormone is an important peptide hormone that stimulates growth, cell reproduction, and cell regeneration. Measuring growth hormone in the blood is an important clinical assay, but may be problematic due to heterogeneity of the hormone that may arise from alternative splicing, different post-translational or...