A US federal appeal court has reinstated lawsuits by Nigerian families against Pfizer in a move that could have wide ranging implications for companies conducting clinical trials abroad.
A FDA warning letter has been sent to a clinical investigator who administered incorrect doses of investigational drugs having taken the patient’s weight and height from their driving license.
UK-based Pharmaceutical Profiles has used an imaging technique known as scintigraphy to quantify the effects of Amylin / Eli Lilly’s latest diabetes drug on the stomach.
Bilcare GCS, the clinical supplies arm of Indian packaging giant Bilcare, has considerably expanded its Phase III trial offering in an effort to provide drugmakers with a complete package.
Merck & Co has been accused of carrying out clinical trials of its Vioxx (rofecoxib) painkiller that were designed primarily for marketing purposes rather than to answer a clinical hypothesis.
The revelation that 49 infants died during clinical trials in India has sparked anger among the nation’s congress, with some calling for all studies to be stopped while investigations take place despite the trials having an infant mortality rate (IMR)...
Panellists serving on the FDA's advisory committees will have stricter limits on their financial ties to industry under a raft of reforms announced by the agency yesterday.
US Senator Sherrod Brown has fired off another broadside in his probe into pharmaceutical outsourcing, this time sending a request to Merck & Co “for further information on its heavy reliance on global outsourcing for the manufacture of pharmaceutical...
A service provider called Binto is filling a much needed vacuum in the clinical trial industry in terms of patient tracking, eliminating the need for big pharmaceutical firms to resort to methods such as hiring private investigators to track down "lost"...
European pharmaceutical manufacturers stepped up calls for a
blanket ban on repackaging of pharmaceuticals last week, suggesting
that this would be the single most effective way to seal the supply
chain for counterfeiting drugs.
A US senator has asked the Food and Drug Administration (FDA) for a
probe into outsourcing of production for pharmaceuticals, as well
as ways to make drugmakers accountable for products which fail to
meet quality standards.
The US Food and Drug Administration has declared the country's
previously-tainted heparin supply to be "safe" due to
stronger testing and controls that are now in place. Meanwhile,
China continues to distance itself...
Questions are hanging over the role of a Chinese manufacturing
facility in the Baxter heparin scare after it has emerged that the
US Food and Drug Administration (FDA) has never inspected the
facility.
