Thursday, March 28, 2024

Thursday, March 28, 2024

Latest News

BECTON DICKINSON AND COMPANY: BD Statement on FDA Circulatory System Devices Panel Regarding Paclitaxel-Coated Devices

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease (PAD) in the superficial femoropopliteal artery (SFA

FDA Update: Which drugs are in short supply?

The Food and Drug Administration this week updated its list of which drugs are in short supply in the nation and which previous drug shortages have been resolved.

Guidance for premarket tobacco product applications for electronic nicotine delivery systems finalized

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.

ZEBRA MEDICAL VISION: Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts

Zebra Medical Vision (https://www.zebra-med.com/), the deep learning medical imaging analytics company, announces today that it has received its third FDA 510(k) clearance for the company's HealthICH product - an AI alert for intracranial hemorrhage (ICH), based on head CT scans.

GEL-E, INC.: Breakthrough Device Designation received from the FDA

gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.

FDA says foods with toxic PFAS chemicals are ‘not a concern’

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.

Should FDA be allowed to share in the profits during its approval process?

A Hawaii doctor opined in a column if the Food and Drug Administration should share in pharmaceutical and medical research profit.

U.S. FOOD AND DRUG ADMINISTRATION: Statement on agency’s efforts to increase transparency in medical device reporting

In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is taking a number of important steps to update its Medical Device Reporting (MDR) Program, one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these products.

U.S., 27 EU nations join drug inspection accord

As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.

Cannabis regulation not in FDA jurisdiction, industry expert says

The Food and Drug Administration has been gathering comments on how to regulate cannabis products, but a cannabis industry expert says FDA should lay off and let states do their jobs.

FDA approves new treatment for pediatric type 2 diabetes

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.

National Center for Health Research wants clearer information disseminated on device predicates

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.

FDA Reporter