news, journals and articles from all over the world.
JAMA recently republished a 1928 article about de-nicotinized tobacco and the potential impact on people struggling to reduce their smoking. Nearly a century later, and despite significant declines over the past several decades, smoking remains a leading cause of morbidity…
A new review in Blood Cancer Discovery outlines a key regulatory decision by an FDA committee that greenlights a new biomarker endpoint for accelerated drug approval in multiple myeloma and could cut a decade off the drug development process.
In a commentary published in JAMA, experts at the Rutgers Institute for Nicotine & Tobacco Studies have issued a call to action to head off the proliferation of nicotine pouches based on lessons learned from electronic-cigarette regulation
Everyone is invited to participate in this exchange of science related to nutrition, innovative ingredients, products and processes in the food and beverage ecosystem.
Kevin Schroth from the Rutgers Institute for Nicotine & Tobacco Studies is available to discuss the Supreme Court’s November 25 decision rejecting RJ Reynolds’ appeal in its fight against graphic cigarette warnings. By declining to hear RJ Reynolds Tobacco Co.…
The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, and world-renowned pathologist Michael Laposata, MD, PhD, today announced the filing of a lawsuit challenging the recent U.S. Food and Drug Administration (FDA) Rule that regulates laboratory developed test (LDT) procedures as medical devices under the Federal Food, Drug, and Cosmetic Act.
A new drug for treatment of a type of brain cancer, called IDH-mutant low-grade glioma, was approved Aug. 6 by the U.S. Food and Drug Administration (FDA). The promising new drug stems from a 2008 genetic discovery made at the Johns Hopkins Kimmel Cancer Center.
Researchers from the University of Arkansas for Medical Sciences (UAMS) have discovered that an FDA-approved cholesterol drug holds the potential to disrupt the progression of Alzheimer’s disease and other forms of dementia.
Live from the annual conference of the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), experts will discuss how the new FDA rule on laboratory developed tests will hinder patient care. This rule will place these tests under duplicative FDA oversight, even though laboratory developed tests are already regulated by the Centers for Medicare & Medicaid Services. This will force many labs to stop performing these essential tests, which play a critical role in diagnosing rare disorders, such as inherited genetic conditions in newborns.
Live from the annual conference of the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC), experts will discuss how the new FDA rule on laboratory developed tests will hinder patient care. This rule will place these tests under duplicative FDA oversight, even though laboratory developed tests are already regulated by the Centers for Medicare & Medicaid Services. This will force many labs to stop performing these essential tests, which play a critical role in diagnosing rare disorders, such as inherited genetic conditions in newborns.
Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the results of a survey that ADLM conducted to determine how the Food and Drug Administration’s (FDA’s) final laboratory developed tests rule will impact patient access to essential tests. The survey found that, in spite of certain tests being exempt from the rule, it will still force many laboratories, particularly those in hospitals, to discontinue critical tests, including those needed to identify prescription and illegal drug use.
June 20, 2024 (Los Angeles) — Neurologist Leigh Ramos-Platt, MD, Medical Director of the Muscular Dystrophy Association Neuromuscular Clinic at Children’s Hospital Los Angeles (CHLA), is available to comment on the FDA expanded approval of gene therapy for patients with…
The Food and Drug Administration says shellfish from a number of states could be contaminated with toxins that cause paralytic shellfish poisoning. Paralytic shellfish poisoning is caused by eating shellfish contaminated with saxitoxin which causes gastrointestinal distress. According to the…
A new warning from the US Food and Drug Administration says a certain type of baby formula could be contaminated with bacteria. The warning is for Crecelac Infant powdered goat-milk infant formula zero to 12 months, Farmalac baby powdered infant…
The U.S. Food and Drug Administration (FDA) has long sparked controversy with its proposals to regulate laboratory developed tests (LDTs) as medical devices.
Adam Friedman, is a professor and chair of dermatology and serves as residency program director, director of translational research, and director of the supportive oncodermatology clinic in the Department of Dermatology at GW’s School of Medicine and Health Sciences. His…
Event at National Press Club features nutrition, food safety scientists and leaders addressing major issues with a research and regulatory lens.
We at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) strongly disagree with the Food and Drug Administration’s (FDA’s) decision to issue a final rule placing laboratory developed tests under duplicative FDA authority, in addition to these tests’ current regulation under the Centers for Medicare & Medicaid Services (CMS).
The FDA announced 1 in 5 grocery store milk samples tested positive for bird flu. UC Davis experts explain the limits of the test and how to protect yourself from avian influenza.
Adam Friedman, is a professor and the chair of dermatology at GW School of Medicine and Health Sciences. Pooja Sodha, is the director for the center for laser and cosmetic dermatology at GW School of Medicine and Health Sciences.
Rhonda Schwindt, is an associate professor at the GW School of Nursing. She is a nationally certified psychiatric-mental health nurse practitioner with an active clinical practice specializing in LGBTQIA+ health, trauma, and treatment-resistant mood disorders. Amir Afkhami, an expert in…
An FDA advisory committee (ODAC) voted 12-0 today in favor of a major shift in how the agency evaluates new treatments for multiple myeloma. If approved by the FDA, the result will be faster approval of new treatments for multiple myeloma.
“Today, we at the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) provided testimony to Congress regarding the impact of the Food and Drug Administration’s (FDA’s) proposed rule to impose FDA oversight on laboratory developed tests in addition to Centers for Medicare & Medicaid Services (CMS) oversight. While we share FDA’s goal of ensuring that laboratory developed tests are safe and effective, we have serious concerns about the agency’s proposal. If finalized, this rule would create a burdensome dual regulatory structure that would limit patient access to many life-saving tests.
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…
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.
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.
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.
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.
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.
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.
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.
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,…
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…
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…
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,…
Researchers receive $18 million to provide real-time information about new tobacco products, marketing and usage.
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…
A June 13-14 gathering of scientific and regulatory experts at the National Press Club
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…
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…
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).
Afternoons-only, virtual conference features talks on food labels, ‘safe’ ingredients and more.
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.
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…
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.
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.
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.
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…
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…
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…
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