FDA

Includes protections for scientists, promotes openness

September 19, 2007 -- The U.S. House of Representatives passed the Food and Drug Administration Amendments Act that takes steps to protect science and federal scientists at the agency, but fails to address serious conflict of interest issues, according to the Union of Concerned Scientists (UCS). The Senate is expected to pass this legislation.    » read more »

Statement By Francesca Grifo, Union of Concerned Scientists

WASHINGTON (September 21, 2007) - Congress has given final approval to the Food and Drug Administration Revitalization Act, which will hold the FDA more accountable for the drugs it approves. The law requires the agency to publicize the basis for its decision, as well as whether there was any dissent and from whom. This will help ensure that the FDA relies on scientific research in making decisions about new drugs.    » read more »

Measure Will Help To Reduce Overall Costs Of Healthcare

September 21, 2007 -- WASHINGTON, D.C.– Senator Tom Harkin (D-IA) today praised Congress’ final approval of the Food and Drug Administration (FDA) Revitalization Act (S.1082), which reauthorizes important programs to expedite the approval of prescription drugs and medical devices. In addition, the bill improves FDA’s ability to perform post-market surveillance of drugs to prevent unsafe drugs from remaining on the market. President Bush is expected to sign this bill into law soon.    » read more »

(As Prepared for Delivery)

September 21, 2007 -- Every day, families across America rely on the Food and Drug Administration in ways they barely realize. When they put dinner on the table, they are counting on FDA to see that it is free from contamination. When they care for a sick child, they are trusting FDA to make sure the drugs prescribed are safe and effective. From pacemakers to treatments for cancer to the foods we eat, FDA protects the health of millions of Americans, and oversees products that account for a quarter of the US economy.    » read more »

September 13, 2007 -- "Today's report by Cephalon tragically confirms concerns raised by our aggressive investigation into Cephalon's off-label marketing of its drugs. News of confirmed deaths and other adverse reactions adds urgency and immediacy to our active and ongoing investigation. Our serious and significant concerns about this drug, already substantiated by evidence, are likely to support efforts for remedial action.    » read more »

September 2, 2007 -- Connecticut Governor M. Jodi Rell announced today that the U.S. Food and Drug Administration (FDA) has heeded her call to reconsider a plan to close seven of 13 field testing laboratories.    » read more »

Jerusalem, Israel, August 27, 2007 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that, following the expiration of pediatric exclusivity for U.S. Patent No. 4,743,450, the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's hypertension treatment Accupril® (Quinapril Hydrochloride Tablets, 5 mg, 10 mg, 20 mg and 40 mg. Shipment of this product will commence shortly.    » read more »

08/23/2007 -- WASHINGTON - Senator John Kerry issued the following statement today in response to a new set of regulations proposed by the Food and Drug
Administration. Kerry has been working with Senate colleagues to
encourage the FDA to take strong steps to improve misleading labeling, a lack of standards and questions about toxicity in sunscreens.

"Today's proposal to create a useful rating system is a good step that
is long overdue," Kerry said. "Everyday parents buy sunscreen to protect
their children from skin cancer and sun damage but we know very little    » read more »

MINNEAPOLIS – August 21, 2007 – Medtronic, Inc. (NYSE:MDT) announced it has been informed by the U.S. Food and Drug Administration (FDA) that an Advisory Panel will review the Premarket Approval (PMA) application for the Endeavor® Drug Eluting Coronary Stent in October. The FDA will announce the date and the complete agenda four to six weeks prior to the meeting in accordance with their normal communications regarding public panel meetings.    » read more »

Titusville, N.J., (August 22, 2007) -- The U.S. Food and Drug Administration (FDA) today approved RISPERDAL® (risperidone) for the treatment of schizophrenia in adolescents ages 13-17 and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.    » read more »

21 August 2007 -- The U.S. Food and Drug Administration recently issued a warning that parents not give young children commercially sold cough and cold medicine, unless a doctor approves it first. The concern came after a two-year study of at least 1,500 children who were hospitalized after taking the syrup.

Cough and cold medications line the shelves of neighborhood pharmacies almost everywhere. Most of the labels on the back warn parents not to give the syrup to children under the age of two. Some medications extend the age to six.    » read more »

July 31, 2007 -- Connecticut Attorney General Richard Blumenthal today, in congressional testimony, demanded federal action on his three-year-old petition to require stronger label warnings on OxyContin and urged stronger criminal sanctions to prevent future tragedy.

More than 300 people have died from OxyContin overdoses, while Purdue Pharma has made hundreds of millions of dollars in profits, Blumenthal said.    » read more »

July 26, 2007 -- On July 24, 2007 the U.S. Food and Drug Administration (FDA) was informed by Targeted Genetics Corporation of Seattle about the death of a patient who received an investigational gene therapy product in a clinical trial for the treatment of active inflammatory arthritis.

FDA's condolences go to the patient's family.

FDA is providing this preliminary information in recognition of the public's interest in these types of new therapies.    » read more »

uly 27, 2007 -- The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.    » read more »