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.
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)...