The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products. They are the government agency responsible for reviewing, approving and regulating medical products, including pharmaceutical drugs and medical devices.
To provide insight on the utility and practicality of implementing a pharmacist-driven pharmacogenomics program in a community pharmacy or primary care setting and to provide a clinical updat...
On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) for the use of Next Generation Sequencing (NGS) for tumor profiling i...
Advancements and innovation in in vitro diagnostic device (IVD) development are important for the success of personalized medicine. This is highlighted by the dramatic increase in the number...
A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that...
For a plant that has been legal in some states for over 20 years, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary rese...
Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for thera...
DATE: February 27, 2018TIME: 8:00AM PST, 11:00AM EST The complexity of the manufacturing process of probiotic supplements, along with increased demand and strict criteria f...
GPCRs constitute the largest receptor family in the human genome. Over the years they have proven themselves to be druggable targets accounting for about 1/3 of all drugs on the market today....
There is an acute shortage of organs due to disease, trauma, congenital defects, and most importantly, age related maladies. The synthetic materials used in tissue engineering applications to...
Preterm birth (PTB) is the leading cause of infant mortality and morbidity worldwide. Both preterm labor and neonatal injuries have been linked to inflammation. Of all mediators of inflammati...
The path form biomarker discovery to conversion to a clinically useful companion diagnostic test presents many challenges. The talk will outline the regulatory requirements to developing a su...
Precision medicine allows for prediction of drug response and tailoring drug therapy based on genetic variability. This talk will provide examples of precision medicine initiatives at the Uni...
The distinction between "complementary" and "companion" diagnostics tests confuse many physicians and healthcare professionals. Panelists Professor Thomas Webster (Northea...
There are many tumor biomarkers but, they mostly reflect tumor mass or past growth, when what is more important is to obtain an indication of future growth and therapy response.Proliferat...
One-third of FDA-approved drugs target G protein-coupled receptors (GPCRs), transmembrane cell surface proteins that recognize small molecules and polypeptides with diverse chemical scaffolds...
DATE: January 30, 2018TIME: 9:00AM PST, 12:00PM ESTInfectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatica...
QuantiFERON TB (QFT) was the first interferon gamma release assay (IGRA) utilizing whole blood stimulation as a test for TB infection, gaining FDA approval in 2001. Subsequently there have be...
The role of the microbiology laboratory in the processing of positive patient blood cultures has become more complicated with the increasing demand for rapid information to assist in the mana...
This webinar builds and expands on the recent labroots webinar by Dr. Gary Horowitz to emphasize how relatively in expensive assay standardization procedures can be incorporated into clinical...
The integration of next-generation sequencing (NGS) tests into clinical laboratory practice across medical disciplines provides medically actionable data that in some cases are not otherwise...
Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than ever for curative effects. However, many technical challenges in T c...
DATE: October 19, 2017TIME: 08:00am PDT, 11:00am EDT Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than...
DATE: October 18, 2017TIME: 8:00 AM PST, 11:00 AM ESTOver the past decade, 25-OH vitamin D has become one of the most common assays requested by physicians.The increase in testing volum...
To provide insight on the utility and practicality of implementing a pharmacist-driven pharmacogenomics program in a community pharmacy or primary care setting and to provide a clinical updat...
On March 16, 2018, the Centers for Medicare and Medicaid Services (CMS) finalized a National Coverage Determination (NCD) for the use of Next Generation Sequencing (NGS) for tumor profiling i...
Advancements and innovation in in vitro diagnostic device (IVD) development are important for the success of personalized medicine. This is highlighted by the dramatic increase in the number...
A recent report by CPhI highlights the pharmaceutical industry drive to improve productivity by improving right first time quality and reducing overhead costs1. Another report indicates that...
For a plant that has been legal in some states for over 20 years, there has been an attitude that “cannabis never killed anyone.” While we don’t have the necessary rese...
Although more than half of U.S. states have legalized the use of medical marijuana, the U.S. Food and Drug Administration (FDA) has not yet recognized or approved the cannabis plant for thera...
DATE: February 27, 2018TIME: 8:00AM PST, 11:00AM EST The complexity of the manufacturing process of probiotic supplements, along with increased demand and strict criteria f...
GPCRs constitute the largest receptor family in the human genome. Over the years they have proven themselves to be druggable targets accounting for about 1/3 of all drugs on the market today....
There is an acute shortage of organs due to disease, trauma, congenital defects, and most importantly, age related maladies. The synthetic materials used in tissue engineering applications to...
Preterm birth (PTB) is the leading cause of infant mortality and morbidity worldwide. Both preterm labor and neonatal injuries have been linked to inflammation. Of all mediators of inflammati...
The path form biomarker discovery to conversion to a clinically useful companion diagnostic test presents many challenges. The talk will outline the regulatory requirements to developing a su...
Precision medicine allows for prediction of drug response and tailoring drug therapy based on genetic variability. This talk will provide examples of precision medicine initiatives at the Uni...
The distinction between "complementary" and "companion" diagnostics tests confuse many physicians and healthcare professionals. Panelists Professor Thomas Webster (Northea...
There are many tumor biomarkers but, they mostly reflect tumor mass or past growth, when what is more important is to obtain an indication of future growth and therapy response.Proliferat...
One-third of FDA-approved drugs target G protein-coupled receptors (GPCRs), transmembrane cell surface proteins that recognize small molecules and polypeptides with diverse chemical scaffolds...
DATE: January 30, 2018TIME: 9:00AM PST, 12:00PM ESTInfectious disease surveillance and monitoring is critical in settings where disease outbreaks and antibiotic resistance can dramatica...
QuantiFERON TB (QFT) was the first interferon gamma release assay (IGRA) utilizing whole blood stimulation as a test for TB infection, gaining FDA approval in 2001. Subsequently there have be...
The role of the microbiology laboratory in the processing of positive patient blood cultures has become more complicated with the increasing demand for rapid information to assist in the mana...
This webinar builds and expands on the recent labroots webinar by Dr. Gary Horowitz to emphasize how relatively in expensive assay standardization procedures can be incorporated into clinical...
The integration of next-generation sequencing (NGS) tests into clinical laboratory practice across medical disciplines provides medically actionable data that in some cases are not otherwise...
Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than ever for curative effects. However, many technical challenges in T c...
DATE: October 19, 2017TIME: 08:00am PDT, 11:00am EDT Recent FDA approval of the first Chimeric Antigen Receptor T cell (CAR-T) therapy offers cancer patients more promise than...
DATE: October 18, 2017TIME: 8:00 AM PST, 11:00 AM ESTOver the past decade, 25-OH vitamin D has become one of the most common assays requested by physicians.The increase in testing volum...
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