Tag: FDA

New Rutgers Saliva Test for Coronavirus Gets FDA Approval

sarah JonasFeature

The FDA has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency. The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs.

FDA Approves First Plasma Therapy for Houston Methodist COVID-19 Patient

sarah JonasFeature

Houston Methodist received FDA approval Saturday to become the first academic medical center in the nation to transfuse donated plasma from a recovered COVID-19 patient into a critically ill patient. This treatment was fast-tracked to the bedside over the weekend as the death toll in the COVID-19 pandemic soared to more than 2,000 people across the United States, with more than 100,000 Americans sick from the virus.

AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

sarah JonasPolicy

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.

Researchers Show How Ebola Virus Hijacks Host Lipids

sarah JonasResearch Results

Robert Stahelin studies some of the world’s deadliest viruses. Filoviruses, including Ebola virus and Marburg virus, cause viral hemorrhagic fever with high fatality rates. Stahelin, professor at Purdue University, examines how these viruses take advantage of human host cells.

Expert on #FDA’s #Expanded Access program: Cost can be a barrier to critically ill patients, healthcare providers, and others seeking to try experimental treatments as a last resort. Dr. Marjorie A. Speers available to comment or participate in inter

sarah JonasExpert Pitch

Costs related to the expanded access procedure under which critically ill patients can  try experimental drugs, biologics, and medical devices are often overlooked. These costs, according to Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D. can become a barrier for patients,…

Expert in #expandedaccess to experimental drugs and diversity in clinical trials to speak at D.C. conf., and is available for interviews

sarah JonasExpert Pitch

An international expert in expanded access to experimental drugs, Marjorie A. Speers, Ph.D., will speak at the third annual Expanded Access Summit Jan. 27-29 at the National Press Club in Washington, D.C. Speers, a former CDC official, is the executive…

ANALYSIS OF FDA DOCUMENTS REVEALS INADEQUATE MONITORING OF KEY PROGRAM TO PROMOTE SAFE OPIOID USE

sarah JonasResearch Results

A risk-management program set up in 2012 by the U.S. Food and Drug Administration to curb improper prescribing of extended-release and long-acting opioids may not have been effective because of shortcomings in the program’s design and execution, according to a paper from researchers at the Johns Hopkins Bloomberg School of Public Health.

Rutgers Tobacco, Vaping Expert Available to Discuss FDA’s Finalized Enforcement Policy Targeting Flavored E-cigarettes That Appeal to Youth

sarah JonasExpert Pitch

Rutgers Tobacco, Vaping Expert Available to Discuss FDA’s Finalized Enforcement Policy Targeting Flavored E-cigarettes That Appeal to Youth A Rutgers University expert on tobacco and vaping is available to comment on the FDA’s enforcement policy on unauthorized flavored cartridge-or pod-based…

FDA awards $1.7 million to IU and other universities for quality management research

sarah JonasAnnouncement

The U.S. Food and Drug Administration has awarded $1.7 million to five universities, including Indiana University, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.

KIDNEY HEALTH INITIATIVE LAUNCHES PROJECT TO MEASURE PATIENT PREFERENCES FOR NOVEL KIDNEY DEVICES

sarah JonasAnnouncement

The US Food and Drug Administration (FDA) has awarded a contract to the Kidney Health Initiative (KHI) to study patient preferences for innovative renal replacement therapy (RRT) devices. The three-year project, “Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy” will capture patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT.

How Oncologists Can Ethically Navigate the “Right-to-Try” Drug Law

sarah JonasResearch Results

The 2018 federal Right to Try Act allows patients with a life-threatening illness to be treated with drugs that have not yet been approved by the Food and Drug Administration (FDA). Many in the oncology community say Right to Try strips away important regulatory protections and view the move as a risky step bound to create ethical dilemmas for physicians whose goal is to guide patients toward safe and appropriate treatment decisions. Oncology is one field at the forefront of requests for unapproved drugs. An interdisciplinary team of bioethicists, oncologists, and lawyers from Penn Medicine and other institutions penned a commentary published online this week in the Journal of Clinical Oncology to offer recommendations to help oncologists navigate this new “Right to Try” world, while maintaining their ethical obligations to patients.