German drug giant Bayer failed to tell the U.S. Food and Drug Administration of a study that connected a controversial heart surgery drug to dangerous side effects and death, even as FDA convened a panel of experts to evaluate the drug's safety.
But the new observational study (Abuse Rates and Routes of Administration of Reformulated Extended-Release Oxycodone: Initial Findings From a Sentinel Surveillance Sample of Individuals Assessed for Substance Abuse Treatment), suggests a breakthrough.
The CDC performed the study to help the Food and Drug Administration and the USDA, the two main government agencies responsible for regulating food safety, to focus their efforts on preventing food contamination, Dr. Griffin said.
WSJ: Vegetables Are the Main Cause of Food-Borne Illness, CDC Study Finds
Anderson, who heads the paleoclimatology program at the U.S. National Oceanic and Atmospheric Administration and who wasn't involved in the study.
But the results were not good enough for Dendreon to file with the Food and Drug Administration, and they could stoke investor fears that the study might not be big enough to prove Provenge is effective--even if the drug really does save lives.
Each Administration and every major study, review, and strategy document continued to plan for two major operations in overlapping time frames.
This has been a tough thing to pull off but Seattle Genetics says it has been told by the Food and Drug Administration that its study could be sufficient for an approval, despite its small size.
FORBES: Seattle Genetics Scores Win For Smart-Bomb Cancer Drugs
In June 2011, the U.S. Food and Drug Administration issued new regulations on sunscreen, updates that took 34 years of study and deliberation to develop.
FORBES: FDA Delays Implementation Of New Sunscreen Regulations Until After Summer
The Obama administration and EU are continuing to study the Iranian offer, according to American and European diplomats.
Yesterday, Orexigen, which seemed to have abandoned its obesity drug Contrave after the Food and Drug Administration asked for a giant study to prove the medicine is safe, jumped back in the weight-loss game .
Merck has so far declined to conduct a big, expensive study to establish that Gardasil can prevent HPV infection in the throat, probably because it would be difficult to use such a study to get regulatory approval from the Food and Drug Administration.
Federal research dollars for study of solar power dwindled after the Carter administration, and oil became cheap and plentiful again.
According to a study announced Aug. 9 by the National Oceanic and Atmospheric Administration (NOAA), the levels of certain vehicle-related pollutants in Los Angeles have dropped by 98% since the 1960s.
Landowners and industry say they're missing out on an economic boom while environmentalists say the administration should have ordered a full health study and has been too opaque about the regulatory process.
On a conference call with reporters, officials with the Food and Drug Administration said they would look at the study.
The study was sponsored by the U.S. Food and Drug Administration.
FORBES: Controversial IOM Report Highly Critical of 510(k) Process
Celgene had previously disclosed that the study, designed to get marketing approval from the Food and Drug Administration for Abraxane in pancreatic cancer, was positive.
FORBES: Celgene's Abraxane Extends Life By 1.8 Months In Advanced Pancreatic Cancer
But critics would say Vioxx's problems started in 2001, two years before Kim fully took over as head of Merck research. (He had just left a job as a biologist at the Massachusetts Institute of Technology.) A U.S. Food and Drug Administration advisory panel was reviewing a large study that proved Vioxx's big selling point: it causes fewer ulcers than cheaper, generic pain pills.
On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
On Monday, Novartis (nyse: NVS - news - people ) said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
Cleveland Clinic cardiologist Steven Nissen, an early critic of Zetia, says the Food and Drug Administration should have demanded Merck begin a giant study comparing Zetia with placebo immediately upon approval.
Dodd , a Democrat, is proposing a sweeping set of drug reforms that would give the Food and Drug Administration the muscle to force pharmaceutical companies to study drug safety after the medicines are approved.
Portland State funded the study along with Oregon Sea Grant, a program of the National Oceanic and Atmospheric Administration.
Experts agreed this study by itself would not pass muster at the U.S. Food and Drug Administration.
The Federal Aviation Administration says it will study the use of portable electronic devices on airplanes, and it is fair to say the airline industry is wary.
FORBES: Airlines Wary of Portable Electronic Devices on Planes
If AtheroGenics had set heart attack, stroke and death as the main goal of its study, these results could lead to approval by the U.S. Food and Drug Administration.
More than 13, 000 patients have been enrolled in one study to test the drug's safety and efficacy for an application with the Food and Drug Administration.
What Cheney and other members of the Bush administration said is that Doug Lute led an Afghanistan study last year, which was given to the Obama transition team and General Jim Jones, and that this White House asked them not to make public.
The study released Thursday was requested by the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration.
CNN: Report on handling H1N1 cases: Use masks with airtight seals
The study involved 26 laboratories and was supported by the European Space Agency and the U.S. National Aeronautics and Space Administration.
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