"Legal Leapfrogging": are Biologics Regulated for Safety, Efficacy and Manufacturing Compliance?

Katherine Watt's legal analysis of the systematic exclusion of Biologics from meaningful regulatory oversight by the FDA, abridged, with my comments and clarification.

This post will explain to you why I never believed that Prasad-Moderna standoff over the mRNA flu injection review/approval is going to last or be effective. My method of predicting the future in this case is very simple. It is because of what is discussed below - the law that absolves “biologic vaccines” from any scientific or technical requirements …