Christian Nagy, a practicing cardiologist and assistant professor at the George Washington University School of Medicine and Health Sciences is board-certified in internal medicine, cardiovascular disease, interventional cardiology and adult congenital heart disease. William Borden is a professor of medicine…
Tag: FDA
New FDA food label initiatives aim to combat diet-related chronic disease by improving nutritional decision making
New initiatives by the U.S. Food and Drug Administration (FDA) aim to combat preventable death and disability caused by poor nutrition by making food nutrition labels easier to understand for consumers. A commentary describing recent and proposed upcoming changes to food labeling is published in Annals of Internal Medicine.
Tattoo inks don’t match the ingredients listed on the bottle
When you get a tattoo, do you know what you’re putting under your skin? According to new research from Binghamton University, State University of New York, the ingredient labels on tattoo ink don’t match the actual substances in the bottle.
Emergency contraception related ER visits dropped significantly over 14 year period
Following federal approval for over the counter emergency contraception in 2006, emergency departments across the U.S. saw dramatic decreases in related visits and medical charges, a new study suggests.
Association for Diagnostics & Laboratory Medicine (formerly AACC) Statement on Proposed FDA Rule on Laboratory Developed Tests
We at the Association for Diagnostics & Laboratory Medicine were disappointed to see the U.S. Food & Drug Administration’s (FDA’s) attempt to circumvent Congress with its new proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under the Centers for Medicare and Medicaid Services.
FDA approving drugs after fewer trials, providing less information to public, OSU studies find
The U.S. Food and Drug Administration is approving more novel pharmaceutical drugs based on single clinical trials and with less public disclosure about those trials than was the norm just a few years ago, a pair of recent studies from Oregon State University found.
Cadmium Intake from Six Foods Analyzed by Age Group
New exposure study suggests that combined consumption estimates of the metal cadmium in common foods may exceed some government health guidance limits for young groups.
Device for treating challenging bone fractures cleared by FDA
A new system for fixing bone fractures, called the Bone Bolt System, has been approved for market by the U.S. Food and Drug Administration (FDA), the University of Utah Orthopaedic Innovation Center (OIC), Department of Orthopaedics and Spencer Fox Eccles School of Medicine announced on July 20, 2023.
Lecanemab FDA Approval: U-Mich Alzheimer’s disease expert available and quote #lecanemab
On July 6, the U.S. Food and Drug Administration granted full approval to the new Alzheimer’s disease drug lecanemab (brand name Leqembi). The medication was granted accelerated approval in January. With the landmark decision, University of Michigan Health, Michigan Medicine,…
UTHealth Houston expert available to discuss anti-Alzheimer’s drug Leqembi ahead of FDA decision
The FDA has granted Priority Review to the anti-Alzheimer’s drug Leqembi for the traditional approval application, with required action from the agency by July 6, 2023. Paul E. Schulz, MD, professor of neurology and director of the Neurocognitive Disorders Center with McGovern…
Ahead of Lecanemab FDA Decision: University of Michigan #Alzheimers expert available for interview
The U.S. Food and Drug Administration is considering full approval of the new Alzheimer’s disease drug Lecanemab (brand name Leqembi), with a decision expected by July 6. University of Michigan Health, Michigan Medicine, has an expert available to talk about…
The Other Dementia Breakthrough—Comprehensive Dementia Care
Most patients with Alzheimer’s disease or other types of dementia will not be eligible for the new disease modifying drugs approved by the FDA for mild cognitive impairment or mild dementia. But an op-ed co-written by UCLA’s Dr. David Reuben,…
Rutgers Tobacco Surveillance Center Will Provide FDA With Unprecedented Data
Researchers receive $18 million to provide real-time information about new tobacco products, marketing and usage.
Blood bank director welcomes FDA blood donation change that will affect members of LGBTQ community
The announcement by the U.S. Food and Drug Administration that it has finalized risk-based guidelines for blood donation related to sexual activity is being welcomed by the longtime director of the Blood Bank at Michigan Medicine, the University of Michigan’s…
Registration Opens for Food and Nutrition Institute’s Annual Conference on Science, Regulation
A June 13-14 gathering of scientific and regulatory experts at the National Press Club
“Put profit margins aside,” says Saint Joseph’s University expert on Narcan over-the-counter approval by FDA
Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter after the FDA authorized the move on March 29. Peter A. Clark, S.J., PhD, is the director of the Institute of Bioethics and professor…
A Registered Dietitian’s Reaction to the New FDA Proposed Rule on Salt
According to the American Heart Association, roughly 90% of Americans are overdoing it on salt, consuming over twice the daily recommended amount. The U.S. Food and Drug Administration (FDA) announced recently it was proposing a rule to allow the use of salt…
Hoelscher appointed to serve on national committee to advise the development of the U.S. Dietary Guidelines
Deanna Hoelscher, PhD, John P. McGovern Professor in Health Promotion and campus dean of UTHealth Houston School of Public Health in Austin, has been appointed to the 2025 Dietary Guidelines Advisory Committee. The Committee will be tasked with reviewing the current body of science on key nutrition topics and developing a scientific report that includes its independent assessment of the evidence and recommendations for the U.S. Department of Health and Human Services and U.S. Food and Drug Administration as they develop the Dietary Guidelines for Americans (the Guidelines).
Dec. 13-15 Science Innovation Showcase Highlights Alternative Proteins, Next-Gen Topics
Afternoons-only, virtual conference features talks on food labels, ‘safe’ ingredients and more.
FDA Approves Oral MEK Inhibitor Cobimetinib for Histiocytic Neoplasms, Research Led by Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center (MSK) announced today that the U.S. Food and Drug Administration (FDA) has approved the oral MEK inhibitor drug cobimetinib (Cotellic®) for the treatment of adult patients with the family of blood diseases known as histiocytic neoplasms (HN). These diseases include Erdheim-Chester disease, Rosai-Dorfman disease, and Langerhans cell histiocytosis. Cobimetinib is an oral inhibitor of MEK1 and MEK2, currently approved to treat melanoma.
Dr. Taghrid Asfar, a Known Expert on Reducing Tobacco Use & Related Deaths, Available to Media
Taghrid Asfar, M.D., M.S.P.H., Sylvester Comprehensive Cancer Center, part of the University of Miami Health System Associate Professor, Division of Epidemiology and Population Health Sciences, Department of Public Health Sciences Dr. Asfar is an internationally known expert on reducing tobacco…
Needs and Challenges for COVID-19 Boosters and Other Vaccines in the U.S.
FAU researchers and collaborators provide the most updated guidance to health care providers and urge how widespread vaccination with these boosters can now avoid the specter of future and more lethal variants becoming a reality.
Research reveals widespread use of ineffective COVID-19 treatments after FDA deauthorized their use
In a paper published in JAMA Network Open, physician-scientists assessed the use of these two monoclonal antibodies for patients with COVID-19 before and after FDA deauthorization.
Increased Precision and Safety in Spinal Tap with PASS – An Ultrasound-Guided Lumbar Puncture Procedure
PASS (Point-Assisted Spinal Sonography), an ultrasound-guided lumbar puncture device from Chula doctors and engineers, helps increase the precision and confidence in spinal tap procedures while reducing risks and pain for patients.
Public Health Experts Comment on FDA Decision to Ban Juul E-cigarettes
WASHINGTON (June 23, 2022)—The Food and Drug Administration said today it will ban the sale of Juul e-cigarettes, saying that Juul played an outside role in the increase in youth vaping. Critics say that Juul used aggressive marketing tactics to…
GW Law Expert Available to Comment on FDA Ban on Sale of Juul e-cigarettes
WASHINGTON (June 22, 2022)— The Food and Drug Administration is reportedly preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, a move that could be announced as early as today. If enacted, the ban would…
Center for Tobacco Studies Experts Available to Comment on F.D.A. Plan to Reduce Nicotine Cigarettes
Experts from the Center for Tobacco Studies, based at Rutgers University, are available to discuss the F.D.A.’s plan to reduce nicotine in cigarettes to help prevent addiction. Since their time, however, is limited here are quotes for pick-up from Andrea…
Mitigating Drug Shortages via a Quality Management Rating System is Viable: New Study
A “quality management maturity” (QMM) rating system for pharmaceutical manufacturing facilities is viable toward reducing drug shortages and increasing medicine availability, according to research by risk management expert Clifford Rossi at the University of Maryland.
Four Things to Know About the Infant Formula Shortage Right Now
Tips from a clinical dietitian for keeping babies healthy when formula is in short supply. It’s no secret the COVID pandemic has brought with it a spate of supply chain challenges. The latest product in crisis: infant and child formula.The shortage has affected nearly all types of formulas, hitting those who require special formulas the hardest: children with milk allergies, developmental disabilities and special needs, among other conditions.
New Oral Antiviral Drug Reduces Death in Early COVID-19
Researchers note that health care providers are now able to add to their armamentarium against COVID-19 their prescription of this new antiviral drug for high-risk, newly-infected patients as soon as possible following diagnosis or within five days of the onset of symptoms.
Registration Opens for Food and Nutrition Science Institute’s Annual Conference
Leading food safety and nutrition scientists are meeting June 21-23, 2022, at the National Press Club.
FAU Expert Answers Questions about Boosters, Vaccines for Children Ages 5-11
Joanna Drowos, D.O., M.P.H., M.B.A., FAU Schmidt College of Medicine, provides answers to some of the most frequently asked questions regarding the COVID-19 boosters and vaccines for children ages 5 to 11.
Why I’ll Vaccinate My Kids
As 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.
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…