The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

The growth of drug development and outsourced clinical work is causing regulatory affairs officials at pharma and biotech firms to increase their workload more than ever before, according to a new study by the Tufts Center for the Study of Drug ...

The US Food and Drug Administration has become more conservative in allowing evidence from non-inferiority clinical trials when considering approval of new drugs, the Government Accountability Office has found 1 . Non-inferiority trials are ...

Top level regulators in Europe have rejected a recommendation that the European Medicines Agency create a dedicated sub-committee to deal with the current overload of applications for generic and biosimilar drugs that are awaiting review via its ...

The US Food and Drug Administration is pressing on with efforts to gather input on how its next prescription drug user fee programme should be framed and consider how performance failures associated with its current user fee programme, PDUFA IV, can ...

Brenda Percy explains why quality should be a part of change management throughout the whole product life-cycle and how to achieve this. Change is often said to be the only constant. This rings true particularly within the pharmaceutical industry, ...

A US congressional committee has begun an investigation into the circumstances surrounding the most recent voluntary recall by McNeil Consumer Healthcare of more than 40 widely used over-the-counter paediatric medicines, including Children?s and ...