While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.
Efforts to streamline the US Food and Drug Administration's expanded access program may be hindered by legal protections that the drugs' sponsors require of prospective patients' providers.
Agency officials have been trying to reduce the time and burden necessary for patients and physicians to gain access to...
Deadlines for reviewing applications for mononational trials in Belgium will be cut by 50%.
The UK MHRA is looking to support drug sponsors in using in silico data during the drug development process – a move that will reduce the use of animal models.
A new decree in Brazil establishes a new ethics governance and operational structure in clinical research and seeks to better protect clinical trial participants.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
Clinical trial sponsors could soon benefit from a streamlined clinical trial approval process in Australia, Canada, Singapore, Switzerland and the UK under a new ACCESS Consortium project.
The FDA reviewed its efforts to bring PROs into cancer drug development at its 10th annual workshop on clinical outcome assessment in cancer trials.
The World Health Organization’s Global Clinical Trials Forum brings optimism for pharma companies and other stakeholders, as it aims to strengthen the clinical trials environment and infrastructure across nations.
