There was an opportunity in the Senate and House bills on FDA reform (the Food and Drug Administration Safety Act of 2007) to do something about this and I as a reformer am disappointed in the failure of both bills to strengthen post-market surveillance.
That is because lawmakers on Capitol Hill want to give the Food and Drug Administration (FDA) sweeping new powers to oversee food production.
But these are unusual times for drug development and its regulation by the Food and Drug Administration (FDA).
"This approval unlocks the potential of gene therapy because it is a first at either the EMA or FDA (U.S. Food and Drug Administration) for gene therapy, " uniQure's chief executive Jorn Aldag said in an interview.
Wilbur estimates that Barr currently has 26 applications pending before the Food and Drug Administration (FDA).
Mixing certain medications for migraine and depression might be risky, warn Food and Drug Administration (FDA) officials.
CNN: Mixing migraine, depression drugs poses risk of serotonin syndrome
The Food and Drug Administration (FDA) is evaluating the safety of over-the-counter cold and cough medications in older children.
CNN: Cold remedies: What works, what doesn't, what can't hurt
The findings are based on reports by the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC).
Some critics had hoped to see a strong regulatory agency, similar to the U.S. Food and Drug Administration (FDA).
CNN: Food Central - European Union to create food safety watchdog
The government is now reviewing the authority of the Food and Drug Administration (FDA) to oversee and control reproductive medicine.
The US Food and Drug Administration (FDA) has approved the "morning-after" pill without a prescription for women aged 15 and over.
The Food and Drug Administration (FDA) is requiring new labels on a birth control patch that delivers hormones through the skin.
The first approach, known as the Kennedy-Waxman bill, will give the beleaguered Food and Drug Administration (FDA) authority to regulate tobacco.
The U.S. Food and Drug Administration (FDA) is currently considering whether to ban the use of menthol as an additive to cigarettes.
FORBES: Will Removing Menthol From Cigarettes Improve Health?
Although the Food and Drug Administration (FDA) said the drug was approvable, it is not expected to hit the market until 2003.
The U.S. Food and Drug Administration (FDA) approved the new swine flu vaccine for use in the United States on September 15, 2009.
Some samples exceeded the "provisional total tolerable intake" (PTTI) set by the US Food and Drug Administration (FDA) by a factor of 120.
The Symplicity renal denervation system is not approved by the U.S. Food and Drug Administration (FDA) for commercial distribution in the United States.
FORBES: Promising One Year Results For Renal Denervation In Resistant Hypertension Spark Hype
The U.S. Food and Drug Administration (FDA) has just announced that Avastin is no longer an approved drug to treat metastatic breast cancer.
FORBES: FDA Hits Avastin, Says Best Selling Breast Cancer Drug Does Not Work
Thank you for communicating your concerns to the U.S. Food and Drug Administration (FDA or the Agency) about the lorcaserin advisory committee meeting.
In fact, a supergeneric will sometimes need a completely new drug application in order to gain approval from the Food and Drug Administration (FDA).
The Family Smoking Prevention and Tobacco Control Act of October, 2009, gave the Food and Drug Administration (FDA) power to regulate smokeless tobacco products.
GlaxoSmithKline today participated in a U.S. Food and Drug Administration (FDA) advisory committee meeting convened to discuss recent findings of porcine circovirus (PCV) in rotavirus vaccines.
In February, regulators at the Food and Drug Administration (FDA) considered adding warnings about such side effects to the labels of both drugs, but decided not to.
Even with its demonstrated successes, MEPACT is still sidelined in the approval process for use in newly diagnosed patients by the U.S. Food and Drug Administration (FDA).
FORBES: For Kids With Cancer, Survival Rates Haven't Moved in 20 Years
Indeed, the results are positive enough that one leading pain expert in the US argues the Food and Drug Administration (FDA) should only license abuse resistant painkillers.
The U.S. Food and Drug Administration (FDA) has convened an advisory panel to evaluate the drug on May 15, and full approval could come as soon as June.
The Food and Drug Administration (FDA) has approved a new drug for treating breast cancer that effectively targets tumors, thus minimizing damage to other cells in the body.
FORBES: Targeted Breast Cancer Drug Ushers in a New Era of Cancer Treatment
The U.S. Food and Drug Administration (FDA) also released preliminary data about the arsenic levels found in 200 rice products they recently tested, which yielded similar results.
FORBES: What's in Your Rice? A Lot of Arsenic, Says Consumer Reports
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