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.
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.
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)...
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.