The increasingly global clinical trial sector demands more effective ethical and regulatory scrutiny according to a study published in the latest edition of the New England Journal of Medicine (NEJM).
UK software group Cisiv has unveiled a web-based EDC platform, Baseline Plus, which is specifically tailored to meet the demands of post market trials.
Coast IRB has decided to close after a probe by US Government Accountability Office (GAO) and subsequent FDA warning letter resulted in the loss of “several key customers”.
From June onwards drug firms and CROs conducting trials in India are required to record full details of the research, including the funding source, on the ICMR’s Clinical Trials Registry India website.
US contractor MeadWestvaco (MWV) claims the latest addition to its Shellpack range, the Shellpak-170, offers drugmakers more options for adherence promotion blister packaging.
Since coming into effect late last year, US Code of Federal Regulations-21 parts 210 and 211 testing rules have been the subject of much confusion in the pharmaceutical industry, according to West Pharmaceutical Services.
SAFC has launched its Vendor Audit Services that are designed to increase clients’ confidence in the supply chain by providing traceability and quality confirmation of raw materials.
Macao Health Bureau director Lam Ping-yan says tabletting delays at Euopharm Laboratories' plant in Hong Kong, China may have led to contamination of the hyperuricemia drug Purinol (allopurinol) linked to several deaths.
PPD says it is unlikely to receive a $25m (€20m) milestone for US approval of Takeda’s diabetes drug alogliptin this year after the FDA said that cardio vascular (CV) safety data filed as part of the NDA are insufficient.
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...
The US Food and Drug Administration (FDA) could raise the bar for
clinical trials of diabetes drugs if it follows the advice of one
of its advisory committees.
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 pilot study looking at a national system for mass serialisation
of medicine packs using 2D matrix coding is due to get underway
next year in Germany.
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.
