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UrduThe 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.
Tag: FDA
FDA Approves Drug Targeting Johns Hopkins-Discovered Brain Cancer Gene Mutation
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 Discover Cholesterol Drug’s Potential as Treatment for Alzheimer’s, Other Dementia
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.
Video and Transcript Available – FDA Changes to Laboratory Developed Test Regulation: Livestreamed Expert Panel
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.
FDA Changing Lab Test Regulations: Livestreamed Expert Panel
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.
Association for Diagnostics & Laboratory Medicine (formerly AACC) survey finds that FDA’s final laboratory developed tests rule will impede the fight against the U.S.’s drug epidemic
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.
Children’s Hospital Los Angeles Neurology Expert Available to Discuss FDA-Approved Gene Therapy Label Expansion for Patients with Duchenne Muscular Dystrophy
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…
FDA Warns of Contaminated Oysters and Clams
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…
Baby Formula Could Be Contaminated with Bacteria, FDA Warns
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…
MEDIA ADVISORY – Webinar: The U.S. FDA’s rule on LDTs – What it means for you
The U.S. Food and Drug Administration (FDA) has long sparked controversy with its proposals to regulate laboratory developed tests (LDTs) as medical devices.
Key Ingredients Not FDA Approved in U.S. Sunscreens
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…
Register for Food and Nutrition Institute’s Fourth Annual Conference on Science, Regulation
Event at National Press Club features nutrition, food safety scientists and leaders addressing major issues with a research and regulatory lens.
The Association for Diagnostics & Laboratory Medicine (formerly AACC) opposes FDA ruling on laboratory developed tests; urges FDA to involve all stakeholders in modernization of laboratory developed test regulation in order to improve patient care
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).
1 in 5 milk samples from grocery stores test positive for bird flu. Why the FDA says it’s still safe to drink
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.
Counterfeit Botox Spreading Through Multiple States
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.
FDA Approves App To Help Treat Depression
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…
FDA’s ODAC Rules Unanimously on a Faster Way to Approve Multiple Myeloma Therapies
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.
Association for Diagnostics & Laboratory Medicine (formerly AACC) Submits Testimony to Congress Opposing FDA’s Proposed LDTs Rule
“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.
FDA Approves Wegovy to Reduce Heart Attack and Stroke Risk
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 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.