Day: October 30, 2025

A key question for the developers of biosimilars is the studies needed to support interchangeability with the reference biologic. A new FDA Guidance Document, released this week, provides the current rationale for the need for a Comparative Efficacy Study (CES). This draft guidance describes updated scientific considerations regarding a comparative clinical study with efficacy endpoints … Read more

Is AI a threat to the medical writers of the World? With the hype around AI bots doing things humans once did, the question is an obvious one, echoing across every knowledge industry and sparking anxiety. Sophisticated algorithms can already generate succinct text and perform lightning-fast data processing, but can they replace the fundamental skill … Read more