The US Food and Drug Administration has given organisations until 3 September to apply for grants to develop new animal drugs intended for minor species or minor uses in major species 1 ,2 . The grants, established under US legislation, could range ...
It's common knowledge that the US and European Union drug regulators often reach different conclusions as to whether a pharmaceutical product should be approved, withdrawn or restricted. Those differences have been thrown into even sharper relief by ...
Michael Rosenberg explains how adaptive monitoring can be a better way of tracking investigative site quality and performance. You never thought it possible: the clinical trial under your organisation's management is coming under fire for ...
The heads of the US Food and Drug Administration and the National Institutes of Health are working together to improve the approval process for companion diagnostics. They hope to establish a level of regulation that ?both protects patients and ...
The European Medicines Agency has adopted a document that explains an optional procedure under which sponsors can request a scientific recommendation from the agency?s Committee for Advanced Therapies in order to establish whether a product should ...
The Human Tissues Working Party of UK charity the Safer Medicines Trust believes that individuals on the organ donor register should be asked about the possibility of donating tissues that would be removed solely for use in research (ie not for ...
A somatic cell therapy for treating cardiovascular diseases has become the first product to obtain certification of experimental data by the European Medicines Agency under the European Union?s framework for advanced therapy medicinal products 1 ,2 ...
The UK Medicines and Healthcare Products Agency has revised its guidance for notified bodies wanting to consult the agency with regard to medical devices incorporating ancillary medicinal substances 1 ,2 . The latest document replaces an earlier ...
The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to address the issue 1 . In addition to requiring ...
The European Commission has launched a public consultation to identify the strengths and weaknesses of the current legal framework for veterinary medicinal products 1 ,2 . Specifically, the commission is inviting feedback on its plans to put in ...
