News & Analysis on Clinical Trial Services & Contract Research And Development
Some of largest pharmaceutical, biotech and CRO (contract research organizations) companies are beginning preparations for a summit in May to focus on how to manage quality in the outsourcing of clinical trials.
Following its re-elevation to a ministerial level, the Chinese drug regulatory body has rebranded itself the China Food and Drug Administration (CFDA).
BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
ACRO (Association of Contract Research Organizations) is calling on the FDA to clarify draft guidance attempting to mitigate the possible pitfalls in transitioning to electronic source data for clinical investigations.