Category: In the News

Harmonizing measurement and reporting of biomarkers in oncology represents a cross-disciplinary challenge that also cuts across industry, regulatory bodies, academic, and clinical practice. As cancer therapy becomes increasingly targeted, the need for validated biomarker measurement becomes more pressing. In first addressing how biomarkers can be used in conjunction with tumor treatment, said Richard Pazdur, MD,…

The House Energy & Commerce Committee on Wednesday (July 15) passed five bipartisan FDA policy bills that would increase the agency’s authority over imported counterfeit medical devices, stop gaming of certain orphan drug exclusivity provisions, boost use of continuous manufacturing, empower FDA to require labeling updates for generic drugs, and allow the agency to add…

The FDA announced a new research project to collect real-world data from insurance companies and electronic health records on the use of diagnostic tests and medications for COVID-19. The agency is partnering with New York–based health tech company Aetion for the project.   Together, the FDA and Aetion hope to use advanced analytic techniques to…

A White House effort to undermine Anthony S. Fauci has drawn rebukes from public health experts, scientists and mostly Democratic politicians, who argue it is dangerous for the Trump administration to disparage a highly respected government infectious-disease expert as the novel coronavirus continues to exact a heavy toll on the nation.   The angry reaction…

On June 18, 2020, the U.S. Food and Drug Administration (FDA) took an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA announced its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics…

As the 21st Century Cures Act approaches its 4th anniversary, the National Comprehensive Cancer Network® (NCCN®) convened a working group made up of multidisciplinary experts from across the country to analyze current issues related to the 21st Century Cures Act and to develop recommendations for future policy improvements. The Co-Chairs of the working group—Jeff Allen,…

Executive Summary Duke-Margolis’ Mark McClellan touts the advantages networks have over individual operations, citing the dexamethasone RECOVERY trial, and notes need for real-world evidence infrastructure. In gathering data on potential COVID-19 therapeutics, clinical trial networks can accomplish what individual study sites are unable to do, Mark McClellan, director of the Duke-Margolis Center for Health Policy…

Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used PCR-based diagnostics and serological antibody tests. The Reagan-Udall Foundation for the FDA and…

Covid-19 vaccine tests should include racial and ethnic minorities, pregnant women, and patients with underlying health conditions, the FDA said, echoing calls from patient advocates to broaden the pool of participants.   The Food and Drug Administration released guidance Tuesday that laid out the criteria for companies like Moderna Inc., Sanofi, and Johnson & Johnson…

Real-world data is everywhere. During the COVID-19 global pandemic, we are literally generating, and collecting, real-world data every single day—from electronic health records, insurance claims, patient registries, and a myriad of other sources. But the question remains: how do we use this data to better understand, prevent, and treat this disease?   Data by itself…