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).

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.

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.

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.

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).

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.

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.

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…

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.

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…

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.

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%.