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 ...

A post-inspection letter from the US Food and Drug Administration raising concerns about a pharmaceutical company?s facilities may be unwelcome, but it could also be seen as an opportunity, according to one expert. Though form FDA 483 letters ...

An Australian Senate committee has called off its inquiry into a major medicines pricing bill in view of the hung Parliament that has resulted from the federal elections 1 ,2 . The Community Affairs Legislation Committee was due to submit its final ...

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 ...

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 ...

The US Food and Drug Administration has issued guidance explaining how and why manufacturers of biological products should submit their lot distribution reports (LDRs) electronically rather than as paper submissions 1 . The guidance, which follows ...

India's department of industrial policy and promotion (DIPP) has put out a "discussion paper" on the controversial subject of compulsory licences, aimed at developing a "predictable environment" for the use of such measures in the area of medicines ...

The US Supreme Court has agreed to review Matrixx Initiatives Inc v Siracusano, a case that has the potential to determine which adverse event reports a drug maker must disclose to shareholders to avoid securities suits 1 . Specifically, the case ...

Problems relating to the mechanism in which manufacturers supply drugs to wholesalers in the UK are resulting in many patients still not receiving the medicines they need when they need them. This was the consensus at the general meeting of the ...

In what has implications for the US biosimilar sector, a federal judge has denied a request by sanofi-aventis for a preliminary injunction that would have directed the US Food and Drug Administration to suspend and withdraw its approval of a generic ...

An Australian court has admitted a petition challenging the validity of a patent for a human gene (BRCA1) associated with breast cancer 1 ,2 . The case ? filed against the three co-owners of the BRCA1 patent (Myriad Genetics, Centre de recherche du ...

A contentious report by the US government?s trade watchdog that reviews its trading partners? intellectual property rights protection policies appears to tread more softly in its demands than it has in previous years, according to some ...