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UrduPeter Loge is an expert in political communication relating to public health initiatives and is the director of the Project on Ethics in Political Communication at the George Washington University School of Media and Public Affairs. Loge can discuss the…
Tag: FDA
Research suggests adults – not just teens – like electronic cigarette flavors
A new study by researchers at Penn State finds that adults enjoy sweet e-cigarette flavors just as much as teens.
Researchers Show How Ebola Virus Hijacks Host Lipids
Robert Stahelin studies some of the world’s deadliest viruses. Filoviruses, including Ebola virus and Marburg virus, cause viral hemorrhagic fever with high fatality rates. Stahelin, professor at Purdue University, examines how these viruses take advantage of human host cells.
Expert on #FDA’s #Expanded Access program: Cost can be a barrier to critically ill patients, healthcare providers, and others seeking to try experimental treatments as a last resort. Dr. Marjorie A. Speers available to comment or participate in inter
Costs related to the expanded access procedure under which critically ill patients can try experimental drugs, biologics, and medical devices are often overlooked. These costs, according to Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D. can become a barrier for patients,…
New drug that could aid earlier MS diagnoses approved by FDA for first human clinical trials
A new drug that could make it easier for doctors to diagnose multiple sclerosis (MS) in its earlier stages has been approved for its first human trials by the U.S. Food and Drug Administration (FDA).
Expert in #expandedaccess to experimental drugs and diversity in clinical trials to speak at D.C. conf., and is available for interviews
An international expert in expanded access to experimental drugs, Marjorie A. Speers, Ph.D., will speak at the third annual Expanded Access Summit Jan. 27-29 at the National Press Club in Washington, D.C. Speers, a former CDC official, is the executive…
ANALYSIS OF FDA DOCUMENTS REVEALS INADEQUATE MONITORING OF KEY PROGRAM TO PROMOTE SAFE OPIOID USE
A risk-management program set up in 2012 by the U.S. Food and Drug Administration to curb improper prescribing of extended-release and long-acting opioids may not have been effective because of shortcomings in the program’s design and execution, according to a paper from researchers at the Johns Hopkins Bloomberg School of Public Health.
Rutgers Tobacco, Vaping Expert Available to Discuss FDA’s Finalized Enforcement Policy Targeting Flavored E-cigarettes That Appeal to Youth
Rutgers Tobacco, Vaping Expert Available to Discuss FDA’s Finalized Enforcement Policy Targeting Flavored E-cigarettes That Appeal to Youth A Rutgers University expert on tobacco and vaping is available to comment on the FDA’s enforcement policy on unauthorized flavored cartridge-or pod-based…
STS Criticizes Dialed-Back E-Cig Flavor Ban
The Society of Thoracic Surgeons (STS) is deeply disappointed that a proposed rule authorizing a nationwide ban of flavored electronic cigarettes (e-cigarettes) did not include menthol.
KIDNEY HEALTH INITIATIVE ANNOUNCES NEW BOARD MEMBERS
Today, seven new members were named to the Kidney Health Initiative (KHI) Board of Directors. KHI is a public-private partnership between the American Society of Nephrology (ASN) and the US Food and Drug Administration (FDA).
ASTRO applauds Senate confirmation of Dr. Stephen Hahn as U.S. Food and Drug Administration Commissioner
The American Society for Radiation Oncology (ASTRO) applauded the U.S. Senate for voting today to confirm radiation oncologist Stephen Hahn, MD, FASTRO, as the next Commissioner of the Food and Drug Administration (FDA).
18-Year Study Examines Miller-Fisher Syndrome After Vaccination
A recent study published in Muscle & Nerve created by the Centers for Disease Control and Prevention/Food and Drug Administration examined the prevalence of Miller-Fisher syndrome (MFS) occurring after vaccination in the United States.
FDA awards $1.7 million to IU and other universities for quality management research
The U.S. Food and Drug Administration has awarded $1.7 million to five universities, including Indiana University, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.
ASTRO supports nomination of Dr. Stephen Hahn to lead U.S. Food and Drug Administration
The American Society for Radiation Oncology (ASTRO) today expressed strong support for the nomination of radiation oncologist Stephen Hahn, MD, FASTRO, as Commissioner of the Food and Drug Administration (FDA). Dr. Hahn served on the ASTRO Board of Directors from 2014 to 2018.
KIDNEY HEALTH INITIATIVE LAUNCHES PROJECT TO MEASURE PATIENT PREFERENCES FOR NOVEL KIDNEY DEVICES
The US Food and Drug Administration (FDA) has awarded a contract to the Kidney Health Initiative (KHI) to study patient preferences for innovative renal replacement therapy (RRT) devices. The three-year project, “Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy” will capture patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT.
How Oncologists Can Ethically Navigate the “Right-to-Try” Drug Law
The 2018 federal Right to Try Act allows patients with a life-threatening illness to be treated with drugs that have not yet been approved by the Food and Drug Administration (FDA). Many in the oncology community say Right to Try strips away important regulatory protections and view the move as a risky step bound to create ethical dilemmas for physicians whose goal is to guide patients toward safe and appropriate treatment decisions. Oncology is one field at the forefront of requests for unapproved drugs. An interdisciplinary team of bioethicists, oncologists, and lawyers from Penn Medicine and other institutions penned a commentary published online this week in the Journal of Clinical Oncology to offer recommendations to help oncologists navigate this new “Right to Try” world, while maintaining their ethical obligations to patients.
FDA approves ultra-low gossypol cottonseed for human, animal consumption
The U.S. Food and Drug Administration has given the green light to ultra-low gossypol cottonseed, ULGCS, to be utilized as human food and in animal feed, something Texas A&M AgriLife researchers have been working on for nearly 25 years.
Rutgers Dean Available to Speak on FDA’s Approval of Second Drug to Prevent HIV
New Brunswick, NJ – Rutgers School of Public Health dean and expert on HIV/AIDS is available to comment on the Food and Drug Administration’s approval of a new drug, Descovy, for the prevention of HIV in men and transgender women.…
Oncologists Respond Swiftly to FDA Safety Alerts, Penn Study Finds
Within six months of the FDA’s move to restrict the label of two immunotherapies, usage of those therapies among oncologists dropped by about 50 percent, according to a new study from researchers in the Abramson Cancer Center at the University of Pennsylvania.