USFDA

- Read more about FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices
The U.S. Food and Drug Administration permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.
- Read more about FDA issues warning letter to doctor for illegally marketing unapproved device with claims to prevent and treat tightening of scar tissue around breast implants
U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also notifies Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs), including deviations from manufacturing processes intended to keep implants sterile.
- Read more about FDA ongoing efforts to stop the spread of illicit opioids, further secure the U.S. drug supply chain and forcefully confront opioid epidemic
The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA.

On the illicit drugs front, worked to increase our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international mail facilities (IMFs). Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing FDA-regulated products and were pulled for FDA review indeed contained illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs.
- Read more about FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.
The U.S. Food and Drug Administration is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. The FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.
- Read more about Nicox announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis
Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis. The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.
- Read more about FDA permits marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium
The U.S. Food and Drug Administration permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.
- Read more about FDA unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
The number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017. This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.
- Read more about FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.
- Read more about FDA new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations
Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.
- Read more about FDA approves first treatment for rare blood disease
The U.S. Food and Drug Administration approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.