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.
The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule. The process and potenti...
I will be discussing the following subjects in my presentation: Update from 2015 PAMA Proposed (or Final Rule) FDA Regulation of LDTs Change to Physician Payment and impact on diagn...
Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
In vitro translation (IVT) using mammalian cell extracts is a quick and convenient alternative to in vivo mammalian protein expression. Thermo Fisher has developed IVT systems from two mammal...
In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests. The legal bar passed by congress in...
Cancer remains the second leading cause of death in the United States. Most tumors arise from a myriad of genetic changes that dysregulate cell growth and prompt survival. Ident...
February 25, 2016, 9:00am PT, 12:00pm ET, 5:00pm GMT
This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 ...
The advent of the microarray technology in 2000 has paved the way for advanced translational research methods that use molecular markers such as microRNA, proteins, metabolites and copy numbe...
The reproducibility of animal studies is now critical to ensure that limited resources are used wisely and that efforts yield useable knowledge. At this time, IACUCs and other similar a...
Diagnostic error impacts millions of US adults and children every year1,2. Failure to order an appropriate diagnostic test and incorrect interpretation of diagnostic test results are co...
Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used...
Cancer immunotherapy has demonstrated promising results. However, to date, researchers have failed to overcome the complex interplay between the immune system and the immune suppressive tumor...
FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests. This use of “enforcement discretion” has been un...
Is your lab constantly challenged by case back log while trying to validate new methods to identify designer drugs? Your challenge is common to many forensic toxicology labs around the world....
While TDM is routinely used in a number of medical fields, it has not gained wide utilization in oncology. There is a growing body of evidence demonstrating that current dosing methods based...
Melanoma, a cancer of pigment-producing cells, accounts for nearly 200,000 new cases of cancer reported each year worldwide. It is the deadliest skin cancer. Alarmingly, in the U.S., the inci...
Biomarkers, with their associated “tsunami” of publications, represent what is arguably one of the largest areas of scientific inquiry in the history of biomedicine. Touted as the...
The landscape for treatment options in metastatic castration resistant prostate cancer has changed dramatically since 2010. There have been more therapies approved since 2010 than in the prio...
DATE: Sept 22, 2015TIME: 9:00am PDT, 12:00PM EDTHeart failure is a complex syndrome and affects over 5.1 Million Americans today with approximately 500,000 new heart failure cases each year. ...
Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Influenza, together with pneumonia, is the leading infectio...
Matching the mutational profile of a patient's tumor with appropriate targeted agents is a goal of personalized medicine in oncology. The number of FDA-approved targeted therapies, as well as...
CMS continues to make changes to how all healthcare providers are reimbursed in attempts to control the cost of the services provided to Medicare beneficiaries. This has led to value-based r...
This educational session will focus on some of the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials. USP has rece...
The hippocampal formation is one of the most extensively studied regions of the brain, with well described anatomy and basic physiology; moreover, aspects of human memory mediated by hippocam...
The Centers for Medicare and Medicaid Services (CMS) is about to gather reimbursement data from laboratories to recalculate the clinical laboratory fee schedule. The process and potenti...
I will be discussing the following subjects in my presentation: Update from 2015 PAMA Proposed (or Final Rule) FDA Regulation of LDTs Change to Physician Payment and impact on diagn...
Emerging technologies facilitate basic science research, but their value in regulatory applications requires rigorous assessment and consensus within the research community. Next-generation s...
In vitro translation (IVT) using mammalian cell extracts is a quick and convenient alternative to in vivo mammalian protein expression. Thermo Fisher has developed IVT systems from two mammal...
In this webinar the speaker discusses the approach taken by the Food and Drug administration in their pre-market review of in vitro diagnostic tests. The legal bar passed by congress in...
Cancer remains the second leading cause of death in the United States. Most tumors arise from a myriad of genetic changes that dysregulate cell growth and prompt survival. Ident...
February 25, 2016, 9:00am PT, 12:00pm ET, 5:00pm GMT
This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 ...
The advent of the microarray technology in 2000 has paved the way for advanced translational research methods that use molecular markers such as microRNA, proteins, metabolites and copy numbe...
The reproducibility of animal studies is now critical to ensure that limited resources are used wisely and that efforts yield useable knowledge. At this time, IACUCs and other similar a...
Diagnostic error impacts millions of US adults and children every year1,2. Failure to order an appropriate diagnostic test and incorrect interpretation of diagnostic test results are co...
Basic research in Proteomics has led to new understanding of proteins’ contributions to health and disease, and has also driven the advancement of powerful analytical technologies used...
Cancer immunotherapy has demonstrated promising results. However, to date, researchers have failed to overcome the complex interplay between the immune system and the immune suppressive tumor...
FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests. This use of “enforcement discretion” has been un...
Is your lab constantly challenged by case back log while trying to validate new methods to identify designer drugs? Your challenge is common to many forensic toxicology labs around the world....
While TDM is routinely used in a number of medical fields, it has not gained wide utilization in oncology. There is a growing body of evidence demonstrating that current dosing methods based...
Melanoma, a cancer of pigment-producing cells, accounts for nearly 200,000 new cases of cancer reported each year worldwide. It is the deadliest skin cancer. Alarmingly, in the U.S., the inci...
Biomarkers, with their associated “tsunami” of publications, represent what is arguably one of the largest areas of scientific inquiry in the history of biomedicine. Touted as the...
The landscape for treatment options in metastatic castration resistant prostate cancer has changed dramatically since 2010. There have been more therapies approved since 2010 than in the prio...
DATE: Sept 22, 2015TIME: 9:00am PDT, 12:00PM EDTHeart failure is a complex syndrome and affects over 5.1 Million Americans today with approximately 500,000 new heart failure cases each year. ...
Respiratory viral infections remain a leading cause of medical visits and can contribute significantly to morbidity and mortality. Influenza, together with pneumonia, is the leading infectio...
Matching the mutational profile of a patient's tumor with appropriate targeted agents is a goal of personalized medicine in oncology. The number of FDA-approved targeted therapies, as well as...
CMS continues to make changes to how all healthcare providers are reimbursed in attempts to control the cost of the services provided to Medicare beneficiaries. This has led to value-based r...
This educational session will focus on some of the new demands in counting particles in liquids, with a focus on the challenges of preparing and sampling protein-based materials. USP has rece...
The hippocampal formation is one of the most extensively studied regions of the brain, with well described anatomy and basic physiology; moreover, aspects of human memory mediated by hippocam...
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