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UrduAs the Food and Drug Administration edges closer to emergency use approval of the Pfizer COVID-19 vaccine for children ages 5-11 – which could become available as soon as early November – Rutgers faculty and staff share reasons for why they’ll vaccinate their children.
Tag: FDA
FDA authorization of COVID-19 vaccine for kids 5 to 11: IU experts available to comment
Following a daylong meeting Oct. 26, the FDA authorized Pfizer’s COVID-19 vaccine for use in children ages 5 to 11. This was the first in a series of meetings to make this vaccine available to younger children. Next, the Advisory…
Expert available to comment on Pfizer’s COVID-19 vaccine for kids
Dr. Ishminder Kaur Dr. Kaur is an assistant professor of pediatrics in the division of infectious diseases at the David Geffen School of Medicine at UCLA and the medical director of the pediatric antimicrobial stewardship program at UCLA Mattel Children’s…
AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION COMMENTS ON FDA PROPOSED SUNSCREEN ADMINISTRATIVE ORDER
Statement from AADA President Kenneth J. Tomecki, MD, FAAD
Rutgers Chancellor Available to Discuss COVID-19 Booster Shots, Why Frontline Workers Need Them
Brian L. Strom, chancellor at the Rutgers Biomedical and Health Sciences and executive vice president for Rutgers Health Affairs, is available to discuss the COVID-19 booster shot and why frontline workers need to get them. Strom agrees with the Centers…
“Read Medicine Labels” – How to Safely Use Green Chiretta Against COVID-19
Chula Pharmaceutical Science urges consumers to pay attention to “medicine labels” to choose and use green chiretta (Andrographis paniculata) effectively and safely. They also cautioned that the government should modify the labels, and control the price of herbal medicines that help in curbing the current pandemic.
FDA Meets a Court Deadline, But Fails to Protect America’s Kids from E-cigarettes
Today, the Food and Drug Administration issued decisions on new tobacco product applications, addressing the over 6 million unique products and flavor variations submitted for agency review. Missing from the FDA’s announcement was a decision on a company that has the largest e-cigarette market share – Juul.
JUUL ruling ‘potentially disastrous’ for teens
This week, the FDA will decide whether JUUL’s devices and nicotine pods can stay on the market. The following Cornell University experts are available to discuss the impacts of the ruling. Sunita Sah, associate professor at the SC Johnson School of…
Rutgers Toxicologist Available to Discuss Dangers of Taking Livestock Deworming Drug for COVID-19
Rutgers Professor Lewis Nelson is available to discuss the dangers of people taking the livestock deworming drug ivermectin to try to treat COVID-19. Demand for the drug is surging nationwide despite warnings from the Food and Drug Administration and the…
World-first COVID vaccine booster randomized clinical trial in transplant patients proves third shot is very effective
The study enrolled 120 transplant patients between May 25th and June 3rd. None of them had COVID previously and all of them had received two doses of the Moderna vaccine. Half of the participants received a third shot of the vaccine (at the 2-month mark after their second dose) and the other half received placebo.
The primary outcome was based on antibody level greater than 100 U/ml against the spike protein of the virus. In the placebo group – after three doses (where the third dose was placebo), the response rate was only 18% whereas in the Moderna three-dose group, the response rate was 55%.
Light-Activated Dental Materials – the Latest Dental Innovation of International Standards from Chula
Chula Faculty members joined forces in dental materials science to develop easy-to-use “light-activated dental materials” that meet international standards and help shorten tooth filling time. The secret of these innovative dental materials, made by Thai people, is Acemannan polymer from Aloe Vera that can stimulate the formation of dentin and reduce tooth sensitivity in many dental health products.
UNLV Alzheimer’s Researcher and Expert Panel Present First-Use Recommendations For Aducanumab
A group of six leading Alzheimer’s experts has convened to make the first recommendations for the appropriate use of aducanumab (Aduhelm, Biogen/Eisai), a newly approved treatment for early Alzheimer’s disease. The recommendations will help provide clinicians with greater clarity and…
Johns Hopkins Drug Commercialization Expert Looks at Controversy over Alzheimer’s Treatment
Johns Hopkins Carey Business School Senior Lecturer Supriya Munshaw – an expert in the commercialization of early-stage technologies, especially in the life science and medical device industries – offers her insights into the FDA’s rationale for approving the Alzheimer’s drug aducanumab, the price set by Biogen, the future of FDA leadership, and other related topics, in this Q&A.
Data and safety review board reports how it monitored the COVID-19 vaccine trials
Evaluation of three vaccine candidates during the COVID-19 pandemic fell to 12 experts of the federally appointed COVID-19 Vaccine Data and Safety Monitoring Board. This team has now taken the unusual step of publishing details of their review process in The Journal of Infectious Diseases.
Rutgers Expert Available to Discuss New FDA Approved Drug for Alzheimer’s
A Rutgers neurologist William T. Hu is available to discuss the new drug, Aduhelm, approved by the Food and Drugs Administration to treat Alzheimer’s. “While there is still a lot of work to be done in understanding this drug, we…
Study finds that physicians support pharmacy dispensing in order to expand access to medication abortion
Interviews with primary care providers showed support for removal of the FDA’s mifepristone Risk Evaluation and Mitigation Strategy, which prevents pharmacists from dispensing the drugs needed for medication abortions.
More Care Needed in Interpreting ‘Acceptable Daily Intakes’ in Low-Calorie Sweetener Research
Review of over 100 studies finds mostly correct usage but some slips in interpretation
FDA to ban menthol cigarettes: U-M experts available
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…
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.