Be Wary of Amniotic Fluid Eye Drops, FDA Says
In its ongoing battle against companies selling unapproved stem cell products, the FDA issued a safety communication earlier this month about amniotic fluid eye drops being improperly marketed for dry eye disease. The communication links to earlier letters to two manufacturers — makers of Regener-Eyes and StimulEyes — warning that the products would need an […]
Novel Drug Authorized for Critically Ill COVID-19 Patients
The FDA has issued an emergency use authorization (EUA) for vilobelimab (Gohibic) to treat critically ill adults with COVID-19. In the EUA for the first-in-class monoclonal anti-human complement factor C5a antibody, the agency specified that the therapy be initiated within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). It is given at […]
How Will Medicare’s New Drug Rebate Law Work?
WASHINGTON — The Biden administration issued initial guidance yesterday on how it plans to implement the Medicare drug rebate program, which will affect doctors who administer drugs under Medicare Part B. The program, passed in August 2022 as part of the Inflation Reduction Act, requires manufacturers who raise their drugs’ prices faster than the rate […]
Children in Clinical Trials: FDA’s Proposed Rules of Engagement
FDA issued draft guidance on ethical considerations and special safeguards for having children participate in clinical trials. The new statement addresses how to protect children in clinical investigations for drugs, biological products, and medical devices. Some of the fundamental concepts that the new guidance included for consideration by industry, sponsors, and institutional review boards (IRBs) […]
Experts Break Down What Could Help Improve Access to Paxlovid
Access to Paxlovid, the first oral antiviral treatment for COVID-19, has expanded since the FDA issued an emergency use authorization (EUA) for the Pfizer-made medication in December. However, physicians and pharmacists say there is still more that can be done to make sure the potentially life-saving drug reaches the right people at the right time. […]
FDA Warns on Needle-Free Injection Devices for Facial Fillers
The FDA issued a safety alert on Friday warning against the use of needle-free injection devices for lip or facial fillers — such as hyaluron pens for injecting hyaluronic acid — as these devices are unapproved and have been linked with serious injuries. Patients “may not be aware of the serious adverse events that have […]
DEA Issues Rare Public Safety Alert on Fake Prescription Pills
The Drug Enforcement Administration (DEA) issued a public safety alert on Monday warning of an “alarming increase” in lethal counterfeit pills containing fentanyl or methamphetamine. The alert, the DEA’s first in 6 years, aimed to raise awareness of a significant surge in fake pills mass-produced by criminal drug networks and marketed as legitimate prescription pills. […]
FDA Issues Orders Clarifying Rules for Marketing Sunscreens
WASHINGTON — The FDA on Friday issued two orders officials say are aimed at making sunscreens safer and clarifying requirements regarding active ingredients, although for now there won’t be any noticeable effect on which sunscreen products consumers see on retail shelves. “Americans can reduce risks from sun exposure with continued use of sun protection measures, […]
Surgical Tray Recalled After Two Infant Deaths
Cardinal Health issued a recall of an insertion tray used during emergency intravenous catheter placement for critically ill newborns after its scalpel was implicated in the death of two infants, the FDA said on Friday. Notably, the agency classified this as a class I recall, the most serious type, which is reserved for cases where […]
Medicine Doesn’t Stop at the Bedside
In June 2021, the American Academy of Neurology (AAN) issued a statement recommending the prohibition of neck restraints in law enforcement. Around the same time, the American Medical Association (AMA) issued a statement denouncing the pseudoscientific and racist concept of “excited delirium” and categorized racism as a threat to public health. In 2018, the American […]