Insights
Field notes from a Texas life sciences insurance practice.
USP 797 / USP 800 Compliance and Compounding Pharmacy Insurance: A 2026 Guide
How USP 797 and USP 800 compliance affects compounding pharmacy underwriting, what the 2023 USP 797 revision changed, and an inspection-readiness checklist.
The 2026 GLP-1 Compounding Insurance Crisis: What FDA Enforcement Did to Coverage and How to Re-Paper
March 2026 FDA enforcement against large-scale GLP-1 compounders ended the shortage-list safe harbor and triggered carrier exclusions across the specialty pharmacy market. Here's the coverage landscape and what to do.
Pharmaceutical and Medical Device Recall Insurance: Coverage Architecture, Cost, and What Sponsors Actually Require
The difference between recall expense extensions, contamination coverage, and standalone product recall policies. With benchmarks for limit selection and a summary of what carriers will write in 2025.
Products Liability Insurance for Pharmaceutical and Medical Device Contract Manufacturers: A Buyer's Guide
How premium is calculated, how limits should be selected, what carriers actually underwrite this segment in 2025, and the four endorsements that matter most for a CDMO.
The Pharma MSA Insurance Requirements Guide: Translating Sponsor Contract Language into a Compliant Program
A clause-by-clause translation of the insurance section in a typical pharmaceutical sponsor MSA, with negotiability commentary and a compliance scorecard CDMOs can use before signing.