News & Analysis on Clinical Trial Services & Contract Research And Development
Janssen says an alternative manufacturing approach will restore Doxil supplies, days after Ben Venue Laboratories’ (BVL) entered into consent decree with FDA.
Fuisz Pharma says a new tablet design will be of interest to pharma formulators who find esophageal transit failures hard to swallow.
Following the release of FDA and EMA guidance in 2011 calling for CROs and trial sponsors to take a more risk-based approach to monitoring trials, companies have begun offering products to improve source data verification and more efficiently...
Outsourcing-Pharma.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Parexel, AmerisourceBergen and Norwich Pharmaceuticals.
Despite conflicting media reports and confusion over where India stands in its regulation of clinical trials, Indian drug officials have until the end of January to respond to a Supreme Court order seeking answers on their alleged lax oversight of trials.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials by 2014.