A two-day Food and Drug Administration advisory committee meeting found conflicting reports related to increased late mortality rates in using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs), according to the Regulatory Affairs Professionals Society (RAPS).
A new research study in the JAMA Internal Medicine said most new drug applications are acknowledged by drug companies.
The nonprofit National Center for Health Research (NCHR) said it believes the FDA should make patients aware that devices in the 510 (k) program have not been sufficiently tested on humans through trials, like drugs are tested before being put on the market.
The Victoza injection was approved by the U.S. Food and Drug Administration earlier this month for patients 10 years and older with type 2 diabetes.
Test results from the Food and Drug Administration on food with high levels of fluorinated chemicals known as PFAS were dismissed by two high level officials of the FDA.
The guidance for manufacturers to submit new tobacco product applications through the premarket tobacco product application (PMTA) pathway was finalized on June 11. This is for electronic nicotine delivery systems (ENDS), like vapes, and the associated liquid nicotine.
A new pilot program, Project Facilitate, was announced last week by the Food and Drug Administration to help oncology health-care professionals access unapproved therapies for their cancer patients.
The first World Food Safety Day was held on June 7 with deputy commissioner for food policy and response Frank Yiannas representing the Food and Drug Administration.
R3 Stem Cell and CEO David Green received an untitled letter from the Food and Drug Administration (FDA) for unapproved stem cell products offered at its more than 50 centers around the U.S.
The FDA Drug Approval Process conference in London will provide an overview of procedures and requirements for the U.S. drug approval process.
Zolgensma, a gene therapy to treat spinal muscular atrophy (SMA) in infants, will be the world’s most expensive drug at $2.1 million.
Bipartisan draft legislation was presented by the Senate Committee on Health, Education, Labor and Pensions (HELP) and chairman Lamar Alexander (R-TN) and Patty Murray (D-WA) that includes proposals featuring the use of biosimilars to lower health care costs.
In a safety communication released last week, the Food and Drug Administration warned against unapproved and unauthorized devices for diabetes.
This week, Eli Adashi, Rohit Rajan, and Glenn Cohen will have another paper published in Science that says the FDA is being undermined because of politically motivated congressional legislators, especially recently.
Children aged 6-17 with the autoimmune disorder Lambert-Eaton myasthenic syndrome (LEMS) have the first treatment for their disease with the Food and Drug Administration-approved Ruzurgi.
Two new medicines, Vyndaqel and Vyndamax, were approved for adults by the Food and Drug Administration earlier this month. They will help to treat heart disease caused by transthyretin mediated amyloidosis (ATTR-CM).
FDA acting commissioner Norman Sharpless and deputy commissioner for food policy and response Frank Yiannas released a statement on the changes technology has made on how Americans receive their food.
The Citizens Commission on Human Rights International (CCHR) raised concerns over the Food and Drug Administration approving the Monarch eTNS System for children 7-12 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The Regulatory Education for Industry Annual Conference will be held May 29-30 at the Revere Hotel, 200 Stuart St., Boston.
The FDA will have a hearing on scientific data and information about products containing cannabis or cannabis-derived compounds on May 31 from 8 a.m. to 6 p.m.