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 ...
The US Food and Drug Administration is planning to hold a public hearing on issues that would help advance the development of medical products, including medical devices, drugs and biologics, used in the prevention, diagnosis and treatment of ...
A new rule proposed by the US Department of Heath and Human Services that is designed to strengthen the security and privacy of individual medical records and other health information will have implications for those carrying out clinical research ...
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 ...
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Union drug regulators often reach different conclusions as to whether a pharmaceutical product should be approved, withdrawn or restricted.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 ...
The US Food and Drug Administration plans to implement the next version of the electronic common technical document (eCTD) for regulatory submissions in 2013 and is urging stakeholders to get involved in its development programme. The regulated ...
Drug marketing authorisation holders have until 1 August to submit applications to the UK Medicines and Healthcare products Regulatory Agency to make any labelling changes that might be required for their products to remain in accordance with the ...
The US Food and Drug Administration is seeking stakeholder feedback on its plans to prepare preliminary guidance on the naming, labelling and packaging of medicines to reduce medication errors 1 . On 24-25 June, the FDA will hold a public workshop ...
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 ...
Clinical trial inspectors from the US and the European Union are making strides in a joint inspections pilot programme they embarked on last year to identify how good clinical practice inspections can be conducted more effectively 1,2 . Joint ...
