Three Amgen manufacturing sites, along with Pfizer’s Perth, Australia site are part of a list of more than 100 US FDA Form 483s issued so far in 2015, according to a list obtained by In-Pharmatechnologist.com thanks to the FOIA (Freedom of Information...
The reputation of Indian clinical trials has been damaged by the “unjustified” suspension of medicines tested by GVK Biosciences, Pharmexcil says as it attacks the evidence submitted by French regulators.
Following a May 2014 inspection, US FDA officials have issued a warning letter with multiple cGMP (current good manufacturing practice) deficiencies for Hospira’s manufacturing facility in Liscate, Italy.
The Director of the new 'super' Office of Pharmaceutical Quality must address issues surrounding increasing globalisation and manufacturing complexity, the FDA says as it begins the recruitment process.
Pharma has focused investment in lower risk specialty and orphan diseases to the detriment of 80% of the population, according to Sanofi’s head of R&D who calls for regulatory convergence to help reverse the trend.
Although the abuse-deterrent technology is still relatively new, the FDA has released final guidance explaining to manufacturers how to conduct studies to demonstrate that an opioid formulation has abuse-deterrent properties.