Biotech Values

[WorstLuck]

From the guidelines:

The use of the word should in Agency guidances means that something is suggested or recommended, but
not required

Control can be the vehicle of the investigational drug or another drug

It isn't clear to me how instruction on available controls, none of which are sham, is interpreted to mean that sham might be used in the investigatory arm, let alone a control arm.

I think there is some confusion with the the term "sham injection".

Previously, sham injections were done on an anesthetized eye by pressing an injector with no needle against the eye.

For masking purposes an injection such as is described in the guidelines would be an option. I think the confusion comes from referring to this injection as a "sham injection" when in fact it is an actual injection for masking purposes.

Whether or not the FDA will accept one or another thing can't be known until they do or don't accept it, with the caveat that following the guidelines and other things such as an SPA seems to increase the odds that they will accept it.