As CROs, labs, and other outside partners gain early access to trial and FDA data that sponsor employees have, experts say closing the gap starts with rewriting confidentiality language.
Feature|Articles|September 30, 2026
Life Sciences Compliance: Diagnosis Incomplete
Author(s)Avi Pardo
Life sciences spends billions on compliance — but WhatsApp, iMessage, and SMS conversations between field teams and HCPs remain invisible to oversight.
Advertisement
Advertisement
Life sciences companies operate under some of the most exacting regulatory scrutiny of any industry. From drug development and clinical trials to promotional practices and HCP engagement, pharmaceutical, biotechnology and medical device companies invest enormous resources in compliance: building policies, training employees, monitoring marketing claims and documenting every interaction that touches a regulated process.
Related to this article
Ultragenyx is selling it's Rare Pediatric Disease Priority Review Voucher earned for Genglycos’s approval for $210 million.
A passing FDA inspection tells pharma senior leadership very little about whether the next significant revenue vulnerability is already taking shape. But continuous, AI-enabled quality management maturity (QMM) has the potential to do so months before the issue reaches the realm of P&L.
Lilly’s Foundayo receives a positive CHMP opinion for obesity and type 2 diabetes — putting the oral GLP-1 pill on course for EU approval.
The interleukin-6 receptor inhibitor gains a second indication, though one of two phase 3 trials missed its primary endpoint.
European regulators are increasing pressure on clinical trial sponsors to report study results on time, rolling out new monitoring, reminders and guidance as patient advocates welcome the progress but question whether stronger oversight and enforcement will follow.
Fox Rothschild's Mark Wagner on why drug shortages are so hard to fix — from the definition gap to API dependency to three-year site approvals.
Incubate’s John Stanford on why MFN hits mid-sized pharma harder — fewer products to absorb margin hits and less access to cheap capital.
Advertisement
Advertisement