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 surviva

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 sugg

There’s a particular energy that surrounds a small, emerging biopharma company approaching its first drug launch. It’s a mix of excitement, fear, ambition, and sheer logistical overwhelm; equal parts moonshot and tightrope. For regulatory advertising and promotional consultants, this territory is familiar. It is exhilarating, messy, and incredibly high stakes. And it never fails to reveal the same truth: scientific brilliance does not automatically translate into commercial r

We’re no longer talking to the same people — or in the same way Traditional pharma advertising and promotional strategies that once targeted healthcare professionals, consumers, and payers now require an additional focus: AI platforms. The life sciences and healthcare industries are undergoing a transformative phase with the rise of Generative AI (GenAI). These AI systems, which include Large Language Models (LLMs) like ChatGPT and Gemini, create new content based on their va