The FDA has announced that it will ban menthol cigarettes and flavored cigars within the next year, a move the tobacco industry has pushed against for the last decade. University of Michigan experts can comment. David Mendez and Thuy Le…
Tag: FDA
WashU Expert: FDA menthol ban would benefit Black, younger Americans
The U.S. Food and Drug Administration’s proposed ban on menthol-flavored cigarettes and all flavored cigars could be particularly beneficial for Black and young people, says an expert on tobacco control at Washington University in St. Louis.“Around 80% of adult Black smokers and more than half of people age 18-34 use menthol brands,” said Todd Combs, research assistant professor at the Brown School who works on the Advancing Science & Practice in the Retail Environment (ASPiRE) project, which uses agent-based modeling to test the potential impact of retail tobacco policies.
Rutgers Experts Available to Discuss Proposed Ban on Menthol Cigarettes and Flavored Cigars
Rutgers health experts who study the negative effects of tobacco and advocate for stronger policies and regulations on flavored combustible tobacco products are available to discuss the new proposed ban on menthol cigarettes and flavored cigars by U.S. Food and…
Rutgers Professor Appointed to FDA’s Tobacco Products Scientific Advisory Committee
Cristine Delnevo, director of the Rutgers Center for Tobacco Studies and a professor of Health Behavior, Society, and Policy at the Rutgers School of Public Health, has been appointed to serve on the U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC)
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.
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.
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.
Rutgers Vaccine Expert Available to Discuss Moderna’s FDA Submission
Rutgers’ principal investigator for the Moderna phase 3 coronavirus vaccine clinical trial at Rutgers New Jersey Medical School is available to discuss the drugmaker’s submission of its vaccine to the U.S. Food and Drug Administration for regulatory approval. “It is…
Mass Eye and Ear Experts Urge Food and Drug Administration to Allow Over-The-Counter Hearing Aid Devices
Hearing experts advocate in The New England Journal of Medicine for the FDA to implement the Over-the-Counter Hearing Aid Act of 2017. The FDA missed the deadline to release the much-anticipated regulations on August 18, 2020
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.
What does the @FDA approval of #remdesivir really mean for patients with #covid and the doctors who treat them? @atscommunity
J. Randall Curtis, MD, MPH is Chair in Pulmonary and Critical Care Medicine, Department of Medicine | UW Medicine; past-president of the American Thoracic Society He says with regard to Remdesivir: “I think the data suggests that there is probably some benefit in terms…
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).
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.
Rutgers Experts Urge Ban of Menthol Cigarettes Nationwide
Rutgers experts discuss why actions at the state and federal level need to be taken to ban menthol-flavored tobacco products
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.
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 (PPE) in the COVID-19 era fail to defend against cyberattacks, according to Rutgers and Georgia Tech engineers. Due to the…
Rutgers Expert Available to Discuss Drug Companies’ Safety Pledge on COVID-19 Vaccine Quest
Michael Gusmano, a Rutgers bioethicist and health policy expert, is available to discuss the pledge by drug manufacturers to uphold ethical standards and scientific principles in the global quest for a COVID-19 vaccine. “The safety pledge indicates the pharmaceutical industry…
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.
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).
Dr. Luis Ostrosky available to talk about first Texas randomized study on convalescent plasma
Dr. Luis Ostrosky, professor of infectious disease at McGovern Medical School at UTHealth, co-investigator of first Texas randomized trial for convalescent therapy for COVID-19, is available to discuss latest data and FDA’s hold on the emergency authorization of blood plasma…
Botox Injections May Lessen Depression
By analyzing the FDA database of adverse drug effects, UC San Diego researchers discovered that people who received Botox injections — not just in the forehead — reported depression significantly less often than patients undergoing different treatments for the same conditions.
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.
ISPOR-FDA Summit 2020 on Patient-Preference Information in Medical Devices Is Now Virtual
ISPOR—the professional society for health economics and outcomes research, announced that its joint ISPOR-FDA Summit 2020 has been redesigned as a completely virtual event that will be held September 29, 2020.
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.
The critical role clinical research professionals can play in FDA’s #expandedaccess program.
The Association for Clinical Research Professionals (ACRP) published in their May journal an essay written by Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D. In her piece, Speers discusses the critical role clinical research professionals play in the FDA’s…
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.
SINK COVID-19 study: Can common drugs offer 2-step approach to combat deadly virus?
Researchers at Beaumont Health have begun enrolling patients in a new clinical study aimed at treating COVID-19 patients with two common drugs.
Children’s Fruit Drinks Need Clearer Labels, Finds NYU Study
The labels of drinks marketed to kids do not help parents and other consumers differentiate among fruit juice and sugar-laden, artificially flavored drinks.
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.
Alleviating Confusion around Pain Management Recommendations
New information from NCCN, ASCO, ASH, CDC, FDA, and others seeks to provide clear guidance on how to optimally manage cancer-related pain without exacerbating the ongoing opioid crisis—published jointly in the Journal of the National Comprehensive Cancer Network and JCO Oncology Practice.
Houston Methodist Ramps up Plasma Therapy as FDA Approves Clinical Trial
The FDA’s announcement Friday to approve convalescent serum therapy as a large-scale clinical trial opened the door for more patients to receive the potentially life-saving gift of a donor’s plasma.
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.
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.
White House health communications & ethics expert – COVID-19 response
Peter Loge is an expert in political communication relating to public health initiatives and is the director of the Project on Ethics in Political Communication at the George Washington University School of Media and Public Affairs. Loge can discuss the…
Research suggests adults – not just teens – like electronic cigarette flavors
A new study by researchers at Penn State finds that adults enjoy sweet e-cigarette flavors just as much as teens.
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.
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 often overlooked. These costs, according to Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D. can become a barrier for patients,…
New drug that could aid earlier MS diagnoses approved by FDA for first human clinical trials
A new drug that could make it easier for doctors to diagnose multiple sclerosis (MS) in its earlier stages has been approved for its first human trials by the U.S. Food and Drug Administration (FDA).
Expert in #expandedaccess to experimental drugs and diversity in clinical trials to speak at D.C. conf., and is available for interviews
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
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
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…
STS Criticizes Dialed-Back E-Cig Flavor Ban
The Society of Thoracic Surgeons (STS) is deeply disappointed that a proposed rule authorizing a nationwide ban of flavored electronic cigarettes (e-cigarettes) did not include menthol.
KIDNEY HEALTH INITIATIVE ANNOUNCES NEW BOARD MEMBERS
Today, seven new members were named to the Kidney Health Initiative (KHI) Board of Directors. KHI is a public-private partnership between the American Society of Nephrology (ASN) and the US Food and Drug Administration (FDA).
ASTRO applauds Senate confirmation of Dr. Stephen Hahn as U.S. Food and Drug Administration Commissioner
The American Society for Radiation Oncology (ASTRO) applauded the U.S. Senate for voting today to confirm radiation oncologist Stephen Hahn, MD, FASTRO, as the next Commissioner of the Food and Drug Administration (FDA).
18-Year Study Examines Miller-Fisher Syndrome After Vaccination
A recent study published in Muscle & Nerve created by the Centers for Disease Control and Prevention/Food and Drug Administration examined the prevalence of Miller-Fisher syndrome (MFS) occurring after vaccination in the United States.
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.
ASTRO supports nomination of Dr. Stephen Hahn to lead U.S. Food and Drug Administration
The American Society for Radiation Oncology (ASTRO) today expressed strong support for the nomination of radiation oncologist Stephen Hahn, MD, FASTRO, as Commissioner of the Food and Drug Administration (FDA). Dr. Hahn served on the ASTRO Board of Directors from 2014 to 2018.
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.
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.
FDA approves ultra-low gossypol cottonseed for human, animal consumption
The U.S. Food and Drug Administration has given the green light to ultra-low gossypol cottonseed, ULGCS, to be utilized as human food and in animal feed, something Texas A&M AgriLife researchers have been working on for nearly 25 years.