Drugs

Statement of Brian Wolfman, Director, Litigation Group at Public Citizen

March 4, 2009 -- "We are extremely gratified that the U.S. Supreme Court today in Wyeth v. Levine upheld the traditional right of patients harmed by defective and mislabeled drugs to sue drug companies to recover compensation for their injuries.

Drug companies are not perfect, and they sometimes fail to identify and inform doctors and the Food and Drug Administration (FDA) of problems with their products or their products’ labels. Nor is the FDA perfect. It is overworked and underfunded, and it depends almost entirely on drug companies for information about the safety and effectiveness of drugs.    » read more »

July 18, 2008 -- The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements.    » read more »

XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease

Abbott Park, Illinois, July 2, 2008 -- Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE™ V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE V is the only drug eluting stent to have demonstrated superiority over Boston Scientific's TAXUS® paclitaxel-eluting coronary stent system in two randomized head-to-head clinical trials. XIENCE V will be launched in the United States immediately.    » read more »

FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified

February 11, 2008 -- The U.S. Food and Drug Administration (FDA) announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high "bolus" doses of the drug.    » read more »

February 4, 2008 -- The U.S. Food and Drug Administration (FDA), part of the U.S. Department of Health and Human Services, is requesting nearly $2.4 billion to protect and promote public health as part of the President's fiscal year (FY) 2009 budget—a 5.7 percent increase over the budget that the FDA received for the current fiscal year.

The FY 2009 request, which covers the period of Oct. 1, 2008 through Sept. 30, 2009, includes $1.77 billion in budget authority and $628 million in industry user fees.    » read more »

Steroids among positive stories of declining use

12/11/2007, NEW YORK -- The 2007 Monitoring the Future study (MTF) released today in Washington, D.C., reports promising trends with significant declines in the overall use of illicit drugs among teenagers in the past year, as well as a notable reduction in tobacco use among eighth graders. The decreases are the continuation of a larger downward trend for all measured age groups marking steady long‐term reductions in youth drug use over the past six years (2001‐2007).    » read more »

09/24/2007 -- The Office of the Commissioner of Major League Baseball announced today that Minnesota Twins Minor League player Eli Tintor has received a 50-game suspension for testing positive for a drug of abuse in violation of the Minor League Drug Prevention and Treatment Program.

The suspension will take effect at the start of the 2008 baseball season.

This season, Eli Tintor played for Single-A Beloit of the Midwest League.

Source: MLB

Scientists replicate assembly of antibacterial molecules in a process previously exclusive to cells