Ebola Treatments: FDA, NIH Developing New Clinical Trial Protocol
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA inks agreement with WHO to allow exchange of non-public information about medical products.
You may also be interested in...
Coronavirus Sponsors Should Get Responses To Regulatory Requests Within One Day, US FDA Says
As part of the new Coronavirus Treatment Acceleration Program, FDA staff also are being reassigned to handle investigational therapy requests faster.
Ebola Threat Prompts EU To Focus On Adaptive Licensing
The spread of Ebola to Europe is prompting regulators and industry to explore in more detail adaptive licensing pathways to speed access to potentially life-saving drugs.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.