Rutgers University’s Resilient, Innovative Year Confronting COVID-19

The last year, which has been unlike any other in Rutgers’ 254-year history, has centered on keeping the Rutgers community safe, providing top-notch health care, developing the first saliva test for the coronavirus and helping society cope with the biggest global public health crisis since the 1918 influenza pandemic.

Read more

Alzheimer’s Association again endorses Biogen drug despite mystery data analysis and financial conflict of interest, says Dr. Leslie Norins of Alzheimer’s Germ Quest

Although an expert FDA panel voted ten to one to withhold approval for a Biogen anti-Alzheimer’s drug candidate, the Alzheimer’s Association endorsed the compound. Serious questions have been raised about why, including conflict of interest.

Read more

AACI Applauds Approval of COVID-19 Vaccine, Supports Widespread Vaccination Efforts

The Association of American Cancer Institutes (AACI) commends the U.S. Food and Drug Administration (FDA) for its swift action to grant Emergency Use Authorization (EUA) to Pfizer’s COVID-19 vaccine.

Read more

Remdesivir for COVID-19: FDA Approved but Still Unproven

In a review of evidence from the most reliable data from randomized trials to find likely small-to-moderate effects of remdesivir, researchers say that totality of evidence compiled before the WHO trial results justifies compassionate use of remdesivir for severely ill patients. A smaller trial in China showed significantly decreased mean recovery time but no suggestion of a mortality benefit. ACTT-1 found the same mean recovery time and a suggestion of a mortality benefit that did not achieve statistical significance.

Read more

Rapid disease pathogen identification a step closer following successful UAH startup demonstration

Soon it could only take an hour to find out what pathogen is making you ill, following the successful demonstration of the world’s first multi-pathogen identification using non-amplified RNA detection by GeneCapture, a company cofounded by researchers at The University of Alabama in Huntsville (UAH).

Read more

Menacing Assaults on Science Causing Alarming and Avoidable Deaths in the U.S.

In early 2016, the U.S. was judged to have been best prepared for the existential threat of a pandemic, but turned out to be the least prepared for the actual threat. In a commentary, researchers say that “pandemic politics” is causing assaults on science, the FDA and CDC. They say that politicization of the FDA and CDC is creating continued losses of trust by the U.S. public and continued harm to their longstanding reputations of respect and admiration worldwide.

Read more

Lack of Key Considerations in FDA Food Chemical Safety Process Leaves Consumers at Risk of Chronic Diseases

Today, a group of health, environmental, and consumer organizations challenged the Food and Drug Administration’s (FDA) practice of not accounting for the cumulative health effect of chemicals in the diet when allowing new chemicals in food. Over 60 years ago, Congress passed a law requiring that FDA and industry do just that. Unfortunately, an Environmental Defense Fund investigation of nearly 900 safety determinations found that only one considered the requirement in a meaningful way.

Read more

FDA Guidance Fails to Ensure Security of 3D-Printed Masks and PPE

New Brunswick, N.J. (Sept. 16, 2020) – FDA guidelines for making 3D-printed masks, face shields and other personal protective equipment

Read more

ATS Statement on Latest COVID-19 Policy Actions: Convalescent Plasma and Testing of Asymptomatic Patients

The American Thoracic Society is alarmed by two federal agency policy actions that may significantly impact our nation’s COVID-19 response. This week, the FDA issued an emergency use authorization (EUA) for the use of convalescent plasma to treat COVID-19 disease. This action was taken despite a lack of adequate evidence demonstrating a clear benefit for most patients. As pulmonary and critical care clinicians and researchers who treat individuals with COVID-19, we are concerned that an EUA for convalescent plasma has the potential to put patients at risk.

Read more

AMP Commends Department of Health and Human Services on Decision to Lessen Regulatory Burden on Laboratory Professionals

The Association for Molecular Pathology (AMP), the premier global, molecular diagnostics professional society, commends the decision by the U.S. Department of Health and Human Services (HHS) to rescind the requirement for premarket review of laboratory developed testing procedures (LDPs) by the Food and Drug Administration (FDA).

Read more

Seafood Products Made From Cells Should be Labeled Cell-Based

Companies seeking to commercialize seafood products made from the cells of fish or shellfish should use the term “cell-based” on product labels, according to a Rutgers study – the first of its kind – in the Journal of Food Science. Both the U.S. Food and Drug Administration and U.S. Department of Agriculture require food products to have a “common or usual name” on their labels so consumers can make informed choices about what they’re purchasing.

Read more

KIDNEY HEALTH INITIATIVE URGES INVESTIGATORS TO INCLUDE PEOPLE WITH KIDNEY DISEASES IN CLINICAL TRIALS FOR CORONAVIRUS 2019 (COVID-19) THERAPIES

People with kidney diseases are often excluded from clinical trials because of the complexity and high morbidity of kidney disease.

COVID-19 puts people with kidney diseases at a two to sixteen-fold increased risk of severe symptoms.

All investigators should include people with kidney diseases when developing vaccines, preventative therapies or treatments related to COVID-19.

Read more

FDA Approves First At-Home Saliva Collection Test for Coronavirus

Rutgers’ RUCDR Infinite Biologics received an amended emergency use authorization from the FDA late Thursday for the first SARS-CoV-2 coronavirus test that will allow people to collect their own saliva at home and send to a lab for results. The decision follows the FDA’s recent emergency approval to RUCDR Infinite Biologics for the first saliva-based test, which involves health care workers collecting saliva from individuals at testing sites.

Read more

New Rutgers Saliva Test for Coronavirus Gets FDA Approval

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.

Read more

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

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.

Read more

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

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.

Read more

Researchers Show How Ebola Virus Hijacks Host Lipids

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.

Read more

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

Costs related to the expanded access procedure under which critically ill patients can  try experimental drugs, biologics, and medical devices are

Read more

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

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.

Read more

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

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.

Read more

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

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.

Read more

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

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.

Read more