FDA proposes unique device identification system for medical devices
FDA proposes that most medical devices distributed in the United States carry a unique device identifier or UDI.
Archive for the ‘Drug Safety Information Podcasts’ category
FDA approves Myrbetriq for overactive bladder
The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.
FDA approves Belviq to treat some overweight or obese adults
The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.
FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections
The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods […]
FDA approves first glaucoma stent for use with cataract surgery
Today, the iStent Trabecular Micro-Bypass Stent System, Model GTS100R/L, was approved by the U.S. Food and Drug Administration. This is the first device approved for use in combination with cataract surgery to reduce pressure inside the eye (intraocular pressure) in adult patients with mild or moderate open-angle glaucoma and a cataract who are currently being […]
Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)
Updated FDA Statement on Compounded Versions of hydroxyprogesterone caproate (the active ingredient in Makena)
FDA approves new combination vaccine that protects children against two bacterial diseases
The U.S. Food and Drug Administration today approved Menhibrix, a combination vaccine for infants and children ages 6 weeks through 18 months, for prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b.
FDA urges that oysters, clams, mussels, and some types of scallops from Korea should be removed from the market
The U.S. Food and Drug Administration is urging food distributors, retailers, and food service operators to remove from sale or service all fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the United States. This includes molluscan shellfish from Korea that entered the United […]
FDA approves Perjeta for type of late-stage breast cancer
The U.S. Food and Drug Administration today approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.
U.S. Marshals seized misbranded drugs in Maine
On May 31, 2012, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized drug products from Global Biotechnologies, Inc., of Portland, Maine, pursuant to a warrant issued by the U.S. District Court for the District of Maine.
FDA issues alert on Reumofan Plus
Health officials in Mexico order recall based on potentially harmful pharmaceutical ingredients in Reuofan Plus. The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural� dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.
FDA warns consumers about counterfeit version of Teva’s Adderall
The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance, a […]
FDA warns consumers about counterfeit version of Teva’s Adderall
The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – […]
U.S. Marshals seize unapproved new drug from Crescendo Therapeutics LLC
U.S. Marshals, acting at the request of the Food and Drug Administration, have seized HybriSil (methylprednisolone acetate 1% percentin silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, L.L.C., of Vista, Calif.
FDA-led research team discovers an autoimmune mechanism for serious drug-induced adverse reactions
A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.
FDA approves generic versions of blood thinner Plavix
The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
FDA expands use for FilmArray Respiratory Panel
The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).
FDA proposal aims to help reduce unnecessary radiation exposure for children
Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on […]