Regulatory Affairs Syndicator

The results of a new government study show females may soon be able to fight bone loss as well as breast cancer with a single drug.

Tucson scientists are putting the finishing touches together on a spin-out company from the University of Arizona to develop a drug for valley fever.

WASHINGTON (AP) — Food industry groups that want the same food warning labels to be used nationwide disputed claims Monday that such a requirement would pre-empt some 200 state laws.

Boston Herald - T here are thousands of pills on the market, each with a specific size, shape and color. But the chance that a doctor can identify them is slimmer than some might think. In a recent test, doctors and pharmacists had troubles identifying three common …

FDA is alerting health care professionals that dangerous levels of endotoxins have been found in certain brands of balanced salt solution. These solutions are used to irrigate the eyes, nose and throat during a variety of surgical procedures, includi…

FDA recently approved the first transdermal drug patch for treating major depressive disorder. The patch, called Emsam and marketed by Bristol-Myers Squibb, is applied once a day to deliver the drug selegeline, an MAO inhibitor.

MAO inhibitors …

FDA recently approved Exubera, the first inhaled insulin product. It’s a powdered form of recombinant human insulin that is self-administered using a specially designed inhaler. Exubera, manufactured by Pfizer, is intended to treat types 1 and 2 di…

In February, Hanford Pharmaceuticals announced that it was recalling four lots of Cefazolin for Injection, an antibiotic primarily used in hospitals. Vials in these lots may be contaminated with bacteria that could pose a life-threatening risk for s…

Now for a recall of certain lots and sizes of a surgical product used to repair hernias. The product is the Composix Kugel Mesh Patch and it’s used to repair ventral hernias which usually appear at the site of a prior surgical incision. The patch is…

Roche Diagnostics has recalled certain ACCU-CHEK Aviva glucose meters because an electronic malfunction may cause the meter to show an erroneous result or to become inoperable. To date, three malfunctions have been confirmed in this country and five…

FDA recently issued a public health advisory about the possibility of serious side effects from Trasylol (aprotinin), a drug used to prevent perioperative blood loss in patients undergoing CABG surgery.

The advisory was based on two recently publi…

The manufacturers of the erythropoietic agents Procrit, Aranesp and Epogen have provided updated information about certain antibody-mediated reactions in patients treated with these drugs.

Patients taking these drugs can produce antibodies to er…

FDA has notified healthcare professionals and patients about the continued risk of bacterial meningitis in children with cochlear implants. A new CDC/FDA study followed children with cochlear implants for two years after the device was implanted. T…

FDA is warning parents that turtles can be a source of Salmonellosis, and so they’re not suitable pets in households with small children. In fact, FDA has banned the sale of small turtles since 1975 because of the Salmonella risk.
Salmonella are …