FDA

FDA Approves Human Hookworm Vaccine for Phase I Safety Trials

As any dedicated video game player knows, the first requireme...

FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media

The Food and Drug Administration (FDA) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. The use of these products could result in false results that could lead to significant adverse health consequences. The illegal kits are labeled as: Rapid HIV Test Kit. * Rapid Syphilis Te...

FDA Approves New Drug to Treat Type I and Type II Diabetes

The Food and Drug Administration (FDA) today approved Symlin, an injectable medicine to control blood sugar for adults with type 1 and type 2 diabetes. Symlin is to be used in addition to insulin therapy in patients who cannot achieve adequate control of their blood sugars on intensive insulin therapy alone. Symlin will be the only therapy for the treatment of type 1 diabetes other than in...

FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain

The Food and Drug Administration (FDA) has granted approval to Mylan Technologies, Inc., for the first generic version of Alza Corporation's Duragesic Patch (Fentanyl Transdermal System) used to treat patients suffering from severe chronic pain that cannot be managed with alternative analgesics. When applied to the skin, this patch technology delivers fentanyl, an opioid pain medication that is s...

FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.h...

Nanoparticle Breast Cancer Drug Approved by FDA

Research at Northwestern University Feinberg School of Medicine played a significant role in Food and Drug Administration approval of Abraxane (paclitaxel protein-bound particles for injectable suspension), indicated for the treatment of metastatic breast cancer. "The approval means that women with metastatic breast cancer no longer need to endure the toxicities associated with solvents and will...

FDA Works To Speed The Advent Of New, More Effective Personalized Medicines

As part of an agency-wide initiative to speed development of new medical products through the science of pharmacogenomics, the Food and Drug Administration (FDA) today issued a final guidance titled "Pharmacogenomic Data Submissions." Pharmacogenomics allows health care providers to identify sources of an individual's profile of drug response and predict the best possible treatment option...

FDA Warns About Antipsychotic Drugs and Elderly

The Food and Drug Administration (FDA) today issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., "off-label") use of certain drugs called "atypical antipsychotic drugs." These drugs are approved for the treatment of schizophrenia and mania, but clinical studies of these drugs to treat behavioral...

FDA Approves New Treatment for Chronic Hepatitis B

The Food and Drug Administration (FDA) announced the approval of Baraclude (entecavir) tablets and oral solution for the treatment of chronic hepatitis B in adults. Chronic hepatitis B is a serious disease caused by the hepatitis B virus (HBV) that attacks the liver. The virus can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. According to the...

FDA approves more generic AIDS drugs

Experimenting with Arabidopsis, a fast-growing cousin of the humble mustard plant, scientists at the University of North Carolina at Chapel Hill got a big surprise while investigating how plants respond to attacks from disease organisms such as bacteria and viruses. "Contrary to what we thought we'd find, our experiments showed that at least three different proteins work in concert with on...

Anthrax test, developed by army and CDC, receives FDA approval

A method for identifying Bacillus anthracis, the causative agent of anthrax, has been cleared for diagnostic use by the U.S. Food and Drug Administration (FDA). The test, known as the Gamma Phage Assay, was modified by scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to improve its performance and reliability when used with clinical specimens. The original...

FDA approves child-friendly AIDS medicine

A new website with a Global Information System will provide valuable information for assessing environmental hazards caused by Hurricane Katrina. The National Institute of Environmental Health Sciences (NIEHS), one of the National Institutes of Health, created the website to provide the most up-to-date data to public health and safety workers on contaminants in flood waters, infrastructure and in...

FDA: 'Highly Unlikely' Green Tea Lowers Cancer Risk

The new surgical assistant at the University of North Carolina Hospitals arrived in February sporting three arms, a computerized brain and a glowing track record in helping to repair heart valves, remove cancerous prostates, bypass blocked coronary arteries and perform gastric bypass operations for morbid obesity. The new arrival is a robotic machine, the da Vinci Surgical System, manufact...

FDA approves first medical device using rutgers biomaterial

Rutgers scientists and TyRx Pharma, Inc., have announced the Food and Drug Administration's clearance of a new medical device for hernia repair that incorporates a biodegradable technology developed at the university. This action signals a paradigm shift in the application of biomaterials from permanent prosthetic replacements toward regenerative medicine, in which materials help the body to repa...

Cloning techniques produce FDA-approved antibiotic

The successful synthesis of an antibiotic in a non-native host has provided a team of researchers at the University of Illinois at Urbana-Champaign with the potential for developing new treatments for bacterial infections. The rapid rise of antibiotic resistance poses a serious threat to human health, and demands new treatments effective against resistant pathogens. Fosfomycin is a natural...

FDA causes unnecessary scare about common painkillers

The U.S. Food and Drug Administration (FDA) has caused an unnecessary scare about some pain relievers by adding a warning to drugs that are safe, says Curt Furberg, M.D., Ph.D., from Wake Forest University School of Medicine. At the same time, he says the agency has failed to recognize the harm of a pain reliever that should be taken off the market. "The FDA is adding 'black box' warnings...

FDA sees nanotech challenges in every product category it regulates

WASHINGTON, DC—According to Project on Emerging Nanotechnologies Director David Rejeski, “Today, FDA took a step forward in fulfilling its responsibilities for nanotechnology oversight. If nanotechnology regulation was a baseball game, FDA has scored the first run in the first inning. But the agency must act rapidly to adopt and fully implement the Nanotechnology Task Force’s recommendations....