Regulatory Open Forum

This message was posted by a user wishing to remain anonymous Regardless of whether your clinical trial has any participants, ...

The way an FDA auditor explained this to me was labels for uncleared/approved by FDA may not interfere with the health choices ...

Forgot to mention the additional insights given by section 201(n) of the Act.  It (my paraphrase) says that, if an article is ...

The ANON reply was correct, CMC is required to be submitted outside the annual report.  Please see this link: IND Application ...

The validated range needs to allow for OOS (out of spec) findings. As a result, the validated range must be able to accurately ...

Great question; thanks for circling back. FDA's approach to regulating website representations of a subject device that isn't ...

Medical device manufacturers must follow labelling requirements and appropriate labelling must be done on all Medical Devices ...

Remember that Annex I, Section 23.2 (Information on the label) requires up to nineteen different informational attributes, whereas ...

I'm so excited to finally unveil the new RegEx! Same great community, just now with a more modern look and feel.   If you're ...

Franky, It really depends on what all you are performing work wise. i typically see anywhere from 10-20% which can include the ...