SILVER SPRING, Md.,
May 24,
2024 /PRNewswire/ -- Today, the U.S. Food and
Drug Administration is providing an at-a-glance summary of news
from around the agency:
- On Thursday, the FDA announced that Medline Industries, LP, a
firm marketing and distributing plastic syringes made in
China within the U.S., initiated a
recall to stop using affected products which includes unauthorized
plastic syringes made in China.
Additionally, on Tuesday, the FDA announced that Jiangsu Shenli
Medical Production Co. Ltd, a China-based manufacturer of plastic syringes,
initiated a recall to stop using its unauthorized plastic syringes.
The FDA recommendations have not changed. The FDA will continue
efforts to evaluate problems with syringes made in China and keep the public informed as new or
additional information becomes available.
- On Thursday, the FDA published the "Catching Up with Califf:"
"Treatment Using Medication for Opioid Use Disorder Can Save
Lives," by Robert M. Califf, M.D.,
Commissioner of Food and Drugs. In this "Catching Up with Califf,"
Dr. Califf discusses the new campaign the agency has launched
called "Prescribe with Confidence" to help raise awareness about
OUD and to provide resources for clinicians. There are many people
who could benefit from treatment but who have not received any
medications for OUD.
- On Thursday, the FDA cleared for marketing CamAPS FX by CamDiab
Ltd, a mobile app (prescription-only device) intended for use with
compatible devices for automated insulin dosing to help manage type
1 diabetes in people two years of age or older. This is the first
of its kind for use in pregnant patients who may have complications
from type 1 diabetes. The device works with an integrated
continuous glucose monitor to control a compatible insulin pump.
The app is designed to be compatible with other interoperable
devices that meet pre-specified acceptance criteria in a
predetermined change control plan provided by the sponsor and
cleared by the FDA as part of the premarket submission. This is the
latest example of the FDA's ongoing commitment to help advance the
development and expansion of products that can improve the
management of type 1 diabetes.
- On Thursday, the FDA issued a supplemental approval for
Safe-Guard (fenbendazole) for the treatment and control of
gastrointestinal worms (Aulonocephalus spp.) in wild quail.
This approval provides a tool for wildlife managers to treat and
control these parasites in wild quail populations. While there are
currently FDA-approved drugs for use in farmed quail, this is the
first animal drug approval for use in wild quail and for this
indication.
- On Wednesday, the FDA made new user-friendly updates to the
Searchable Tobacco Products Database including improved search
capabilities and more accommodations for accessing the database on
mobile devices. In March, FDA launched the database, that contains
a list of tobacco products—including
e-cigarettes—that may be legally marketed in
the United States.
Additional Resources:
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration