Jason Cober

Since August 2024, the Agency has issued over a dozen letters that cite time-to-event presentations based on single arm trials. The violations include the following: ● Presentation of disease control rate as a composite of ORR (partial response + complete response) plus stable disease ● Presentation of progression free survival (PFS), overall survival (OS), relapse-free survival (RFS), or disease-specific survival (DSS) as either median survival time or probability of survival ● Presentation of

Since announcing its “crackdown” on DTC pharmaceutical advertising, the US Food and Drug Administration has demonstrated a consistent enforcement focus on oncology presentations of time-to-event endpoints supported by single-arm trials.

Jason Cober, Senior Consultant Regulatory Affairs Ad Promo & Digital Consumer search is rapidly evolving in response to emerging AI capabilities and marketers are adapting content design to ensure products not only appear in search results but are presented accurately in AI summaries and LLM responses. From Google search to email to Adobe Acrobat, AI-generated summaries offer a faster, more efficient channel to connect consumers with search results. Further, recent data suggests there is an...