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.
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...
Date: Tuesday, February 10th, 2015Time: 12:00PM PST, 3:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
Date: Tuesday, February 10th, 2015Time: 9:00AM PST, 12:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
Dr. Oliver Kepp will be presenting on:Immunogenic cell death fingerprinting utilizing a high-throughput screening approachThe strategy of immunogenic cell death fingerprinting has been design...
Although robust and clinically meaningful biomarkers are key to achieving the current vision for precision (molecularly based), cancer medicine (patient stratification, early diagnosis, drug...
The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by...
Traditional testing methods for monoclonal protein in Plasma Cell Dyscrasias correctly identify a majority of patients. However, limitations in these methods can cause patients to be missed...
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...
Date: Tuesday, February 10th, 2015Time: 12:00PM PST, 3:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
Date: Tuesday, February 10th, 2015Time: 9:00AM PST, 12:00PM ESTFor the last 60 years the primary method of preventing cervical cancer in both the U.S. and Europe has been cervical cytology ...
Dr. Oliver Kepp will be presenting on:Immunogenic cell death fingerprinting utilizing a high-throughput screening approachThe strategy of immunogenic cell death fingerprinting has been design...
Although robust and clinically meaningful biomarkers are key to achieving the current vision for precision (molecularly based), cancer medicine (patient stratification, early diagnosis, drug...
The regulation of molecular testing continues to grow in complexity, in terms of the oversight by FDA, coverage determinations by Medicare contractors, and the payment amounts established by...
Traditional testing methods for monoclonal protein in Plasma Cell Dyscrasias correctly identify a majority of patients. However, limitations in these methods can cause patients to be missed...
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