American Regent Initiates Nationwide Voluntary Recall of Epinephrine Injection, USP, 1:1000, 1mL Ampules Lot #1395 Due to Discoloration and Small Visible Particles

American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product:

Epinephrine Injection, USP, 1:1000, 1 mL Ampules NDC #0517-1071-25 Lot #1395, Exp Date: July 2012
Read More

Agent reduces autism-like behaviors in mice

National Institutes of Health researchers have reversed behaviors in mice resembling two of the three core symptoms of autism spectrum disorders (ASD). An experimental compound, called GRN-529, increased social interactions and lessened repetitive self-grooming behavior in a strain of mice that normally display such autism-like behaviors, the researchers say.
Read More

NHGRI to develop revolutionary technologies for exploring genome function

The National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, has awarded 10 grants, totaling $10.5 million, to develop revolutionary technologies that will help researchers identify millions of genomic elements that play a role in determining what genes are expressed and at what levels in different cells. These multi-year grants are part of the Encyclopedia of DNA Elements (ENCODE) project, whose aim is to provide the scientific community with a comprehensive catalog of functional genomic elements that will ultimately help explain the role that the genome plays in health and disease.
Read More

NIH statement on World Malaria Day — April 25, 2012

On World Malaria Day, we stand at a critical juncture in our efforts to control a global scourge. This year’s theme “Sustain Gains, Save Lives: Invest in Malaria” stresses the crucial role of continued investment of resources to maintain hard-won gains. Lives have indeed been saved.
Read More

FDA Statement on USDA Announcement of Positive BSE Test Result

This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or “mad cow” disease). The USDA also confirmed the cow did not enter the animal feed or human food supply. The U.S. Food and Drug Administration is working with federal and state authorities to further investigate this case.
Read More

FDA Continues Dialogue on ‘Nano’ Regulation

The Food and Drug Administration (FDA) is continuing a dialogue on nanotechnology by publishing draft guidelines on the use of nanomaterials in cosmetics and substances added to foods.
Read More

Report: FDA strengthens monitoring of post-approval drug safety

A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.
Read More

U.S. Marshals seize ultrasound gel product at a New Jersey company

U.S. Marshals, acting at the request of the Food and Drug Administration, today seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J. after an FDA analysis found that product samples contained dangerous bacteria.
Read More