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Illinois Gov. Rod Blagojevich has taken another step in his pharmaceutical importation plan by petitioning the FDA for approval to bring in tens of thousands of doses of flu vaccine from wholesalers in the UK.
A consumer protection organization has called on the FDA to investigate AstraZeneca for allegedly delaying the submission of adverse event reports regarding one of its cholesterol-lowering drugs.
In response to the growing controversy over the suppression of negative clinical trial data, Eli Lilly has announced it will disclose all clinical trial results for the drugs its sells on a public registry, beginning the fourth quarter of this year.
A U.S. district court judge’s denial of motions to dismiss negligence claims against AmerisourceBergen and CVS ProCare, which stem from harm caused to a patient by counterfeit Epogen, could establish a legal precedent for defining the liability of manufacturers, distributors and pharmacies for injuries that result from the use of counterfeit drugs, according to an attorney.
Current and former FDA officials, as well as Republican lawmakers, are defending the FDA’s Office of Chief Counsel (OCC), asserting that the agency is empowered by federal law to intervene on behalf of drugmakers in consumer lawsuits and asking that the office not be penalized for doing so.
A physicians' group is calling on Congress and the federal public health establishment to create incentives that will encourage drugmakers to invest more resources into R&D of antibiotic drugs to avert a looming public health crisis.
Just one week after its final rule banning dietary supplements containing ephedra took effect, the FDA has settled the cross hairs of its regulatory sights firmly on the rest of the supplement industry, saying it will more closely monitor the products and vigorously pursue enforcement actions against those it considers unsafe.
The FDA is defending its decision not to allow an agency expert to testify about possible links between the use of some antidepressant drugs and an increased risk of suicide in young people taking the medications.
A pending court case raises the possibility that clinical trial participants have a continuing ownership interest in tissue samples and personally identifiable medical data, creating a potential obstacle for drugmakers trying to develop marketable products using those samples and data.
To thwart drug counterfeiting, the FDA wants drugmakers and distributors to implement electronic tracking systems within the next three years, according to the final report of the agency's Counterfeit Drug Task Force released Feb. 18.