Regulatory Landscape

/Regulatory Landscape

Nothing about us without us

2019-11-03T12:56:57+00:00November 1st, 2019|Categories: Regulatory Landscape|

That was the rallying cry from both investigators and patients at a public meeting on ICH E8 R1, General Considerations for Clinical Studies, held at FDA yesterday. I joined a Webex of the proceedings at different points during the day. The changes to the guideline are significant. It promotes fit for purpose clinical trials by [...]

Keeping up with what is new in clinical research

2019-09-27T06:57:35+00:00September 26th, 2019|Categories: Regulatory Landscape|

There is so much… E8 R1-General Considerations for Clinical Trials has been released for public comment. Generally, I like the changes. Like E6 R2, quality is emphasized but the biggest change is the requirements for patient and treating physician input on the design of the clinical study and the selection of endpoints that are meaningful [...]